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 .
Response to Amendment
The amendments filed on 02/11/2026 has been entered. Claim 1 has been amended; claims 4-7, 10-14, 16, 25, 29, 33, and 35-44 have been withdrawn; claims 9, 20, 22, and 23 have been cancelled. Accordingly, claims 1-3, 8, 15, 17-19, 21, 24, 26-28, and 30-32, and 34 are pending and under examination.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 1 is now rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. US 2016/0159564 A1 (previously cited) in view of Phillips US 2004/0048896 A1 (newly cited). See rejection of claims below.
Applicant's arguments filed on 02/11/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that there is a lack of motivation to combine the prior arts, at least for Rousseau, Mahoney, and Stein on page 15-17 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Rosseau suggests/teaches a retainment means for the freeze-dried component within the container, thus providing motivation for one of ordinary skill in the art to have applied such component to retain the reconstitution component of the Smith in view of Phillips’ device. See rejection of claims 27-28 below. Mahoney suggests/teaches a seal cover comprises product information, which is considered widely known in the field of pharmaceuticals to inform users of the product. See rejection of claims 30-31 below.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 1, 2, 3, 15, 17-19, 21, 26, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. US 2016/0159564 A1 (previously cited, hereinafter Smith) in view of Phillips US 2004/0048896 A1 (newly cited, hereinafter Phillips).
Regarding claim 1, Smith discloses a pharmaceutical unit dose system 100 (Fig. 1 – cup 100, and Par. 2 – “single-serve beverage container for medication”) for oral administration (Par. 5 – “single-serve beverage container wherein the same can be utilized for providing convenience for the user when dispensing a single serving of medication”, and Par. 19 – “the beverage material within the cup 100 to create a medication solution that can later be orally administered to a user”), comprising:
a self-dispersible dry pharmaceutical composition for oral administration (Par. 14 – “The interior volume is adapted to contain a beverage material. In the preferred embodiment, the beverage material is a dehydrated medication”), the self-dispersible dry pharmaceutical composition to self-disperse in the presence of a liquid medium (Par. 15 – “a hot liquid that can mix with the dehydrated medication contained within the interior volume of the cup 100”);
a container 100 (Fig. 1 – cup 100) for packaging and reconstituting the dry pharmaceutical composition (Par. 2 – “the present invention relates a single-serve beverage container including a channel in the interior volume of the container to guide an injected liquid towards a dehydrated medication in order to mix and effectively dispense the medication”), wherein the container 100 (Fig. 1) has volume marking 120 (Fig. 1 – volume marking 120) to allow for appropriate reconstitution and accurate dosing (Par. 17 – “The cup 100 further comprises markings 120 along the sidewall 106 indicating a volume of the beverage material within the interior volume of the cup 100”); and
a seal cover 110 (Fig. 3 – top covering 110) removably secured to the container 100 (Fig. 3, and Par. 15 – “the top covering 110 is composed of foil”; thus, Examiner contends that the foil top covering 110 can be manually removed) by a sealing contact with an opening 104 (Fig. 1 – top portion 104, and Par. 15 – “A puncturable top covering 110 is also disposed across the top portion 104 of the cup 100”) of the container 100 (Fig. 1),
wherein the dry pharmaceutical composition is self-dispersible in the liquid medium after the liquid medium is added to the container 100 (Fig. 1, and Par. 15 – “…inject a hot liquid that can mix with the dehydrated medication contained within the interior volume of the cup 100”; see Claim Interpretation above), and wherein the reconstituted dry pharmaceutical composition is directly used for oral administration from the same container without using an additional container (Par. 19 – “the liquid is mixed with the beverage material within the cup 100 to create a medication solution that can later be orally administered to a user”).
However, Smith does not disclose wherein the self-dispersible dry pharmaceutical composition comprises at least one active agent in the amount of a single administrative dose and at least one pharmaceutically acceptable excipient that allows the self-dispersible dry pharmaceutical composition to self-disperse in the presence of a liquid medium, wherein the container has an interior volume between 10 mL and 30 mL and at least five-fold greater than the volume of the self-dispersible dry pharmaceutical composition, wherein the dry pharmaceutical composition is self-dispersible in the liquid medium within 30 seconds to produce a visually uniform liquid dispersion or solution that is free of visibly undissolved dry matter without manual shaking, stirring, or swirling the container after the liquid medium is added to the container.
Phillips, in the same field of endeavor of orally ad mistering to a patient a pharmaceutical composition and dosage form (Par. 39), teaches wherein the self-dispersible dry pharmaceutical composition comprises at least one active agent (Par. 53 – “"proton pump inhibitor" (or "PPI")… including, but not limited to, omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, pariprazole, and leminoprazole… The definition of "PPI" also means that the active agents of the present invention may be administered”) in the amount of a single administrative dose (Par. 3 – “Typically, omeprazole, lansoprazole and other proton pump inhibitors are formulated in an enteric-coated solid dosage form”) and at least one pharmaceutically acceptable excipient (Par. 82 – “Compressed tablets are solid dosage forms prepared by compacting a formulation containing an active ingredient and excipients selected to aid the processing and improve the properties of the product”) that allows the self-dispersible dry pharmaceutical composition to self-disperse (Par. 91 – “Effervescent tablets and powders are also prepared in accordance with the present invention. Effervescent salts have been used to disperse medicines in water for oral administration”) in the presence of a liquid medium (Par. 91 – water used for effervescence),
wherein the container has an interior volume between 10 mL and 30 mL (Par. 89 –“a 30 ml dose cup”), wherein the dry pharmaceutical composition is self-dispersible in the liquid medium within 30 seconds (Par. 125 – “…it was observed that each tablet was completely dispersed in under three (3) minutes”) to produce a visually uniform liquid dispersion or solution that is free of visibly undissolved dry matter without manual shaking, stirring, or swirling the container after the liquid medium is added to the container (Par. 125 – “each tablet comprising about 20 mg omeprazole and about 975 mg sodium bicarbonate uniformly dispersed throughout the tablet. To test the disintegration rate of the tablets, each was added to 60 ml of water. Using previously prepared liquid omeprazole/sodium bicarbonate solution as a visual comparator, it was observed that each tablet was completely dispersed in under three (3) minutes”, Par. 88, Par. 91, Par. 129 discuss the dissolvement/dispersion of medicine upon added water).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Smith to further include an active agent and an excipient to produce a pharmaceutical composition that can self-disperse in an amount of time as taught by Phillips, in order to enhance the pharmacological activity of a composition (Par. 40 of Phillips) and enhance stability and sterility of the reconstitutable systems (Par. 68-70 of Phillips).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have volume of the container of the combination to be at least five-fold greater than the volume of the dry pharmaceutical composition, in order to fit the particular procedure being done since this claimed dimension of the container does not change the container ability to house the dry pharmaceutical composition and provide mixing space within the container. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see page 11, last paragraph of Applicant’s disclosure), 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 Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 2, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the self- dispersible dry pharmaceutical composition further comprises a preservative (Par. 70 of Phillips), an antioxidant (Par. 70 of Phillips – “various additives can be incorporated into the inventive solution to enhance its stability, sterility and isotonicity. Antimicrobial preservatives, such as ambicin, antioxidants,…”).
Examiner notes that once the modification is made as discussed above, the composition of the combined device will have additives, including a preservative/antioxidant as taught by Phillips.
Regarding claim 3, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the pharmaceutically acceptable excipient comprises a highly water-soluble material, a disintegrant, or a combination thereof (Par. 77 of Phillips – “compressed tablets which rapidly disintegrate after they are placed in water, and are readily dispersible to form a suspension containing a precise dosage of the PPI. The suspension tablets of this invention comprise, in combination, a therapeutic amount of a PPI, a buffering agent, and a disintegrant”).
Examiner notes that once the modification is made as discussed above, the composition of the combined device will have a pharmaceutically acceptable excipient, including a disintegrant as taught by Phillips.
Regarding claim 15, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the active agent is antiulcer agents (Par. 3 of Phillips – “Typically, omeprazole, lansoprazole and other proton pump inhibitors are formulated in an enteric-coated solid dosage form (as either a delayed-release capsule or tablet) or as an intravenous solution (as a product for reconstitution), and are prescribed for short-term treatment of active duodenal ulcers, gastric ulcers”).
Examiner notes that once the modification is made as discussed above, the composition of the combined device will have an active agent, including antiulcer agent as taught by Phillips.
Regarding claim 17, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the liquid medium is water (Par. 15 of Smith – “inject a hot liquid that can mix with the dehydrated medication contained within the interior volume of the cup 100”).
Regarding claim 18, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the container 100 (Fig. 1 of Smith) has a dual function as a primary package compartment (Par. 6 of Smith – “the cup adapted for containing a beverage material, such as dehydrated medication”) and a reconstitution device for the self-dispersible dry pharmaceutical composition (Par. 2 of smith – “an injected liquid towards a dehydrated medication in order to mix and effectively dispense the medication“, and Par. 5 of Smith – “container… can be utilized for providing convenience for the user when dispensing a single serving of medication”).
Regarding claim 19, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the container 100 (Fig. 1 of Smith) is cylindrical or substantially cylindrical (Fig. 1 of Smith and Par. 13 of Smith – “the cup 100 is cylindrical”).
Regarding claim 21, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the volume for reconstitution of the self-dispersible dry pharmaceutical composition indicated by the volume marking 120 (Fig. 1 of Smith – the first or second marking 120 from the bottom) is about or less than 80% of the interior volume defined by the container 100 (Fig. 1 of Smith – the first or second marking 120 on the cup 100 is depicted to be less than 80% of the volume of the cup 100, e.g. the second marking 120 appears to be about 50% or less than the volume of the cup 100).
Regarding claim 26, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the container 100 (Fig. 1 of Smith) is a rigid body container (Par. 13 of Smith – “The cup 100 can be composed of plastic”, which indicates some degree of rigidity).
Regarding claim 32, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the seal cover 110 (Fig. 1 of Smith) is formed of aluminum (Par. 15 of Smith – “the top covering 110 is composed of foil”).
Claims 8 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Phillips as applied to claim 1 above, and further in view of Holthuis et al. US 5,496,801 A (previously cited, hereinafter Holthuis).
Regarding claim 8, Smith in view of Cray in view of Gosau in view of Holthuis discloses the invention of claim 1. However, the combination does not currently disclose wherein the self-dispersible dry pharmaceutical composition is a freeze-dried pharmaceutical composition prepared by in situ freeze-drying a liquid suspension or solution of the pharmaceutical composition in the container.
Holthuis, in the same field of endeavor of reconstitution of a pharmaceutical powder (Col. 5, third paragraph), teaches wherein the self-dispersible dry pharmaceutical composition is a freeze-dried pharmaceutical composition (Col. 5, line 45-46 – “freeze-dried PTH powder…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical composition of the combination to make the pharmaceutical composition a freeze-dried composition as taught by Holthuis, in order to provide an advantage of rapid mixing without shaking (Col. 5, line 47-50 of Holthuis).
Also, the claimed phrase “by in situ freeze-drying a liquid suspension or solution of the pharmaceutical composition in the container” is being treated as a product by process limitation that is a material that results from the process of being freeze-drying in situ in the container. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the applicant that the process of being freeze-dried in situ imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation is being given very little patentable weight.
Claims 24 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Phillips as applied to claim 1 above, and further in view of Gosau et al. US 2022/0265516 A1 (previously cited, hereinafter Gosau).
Regarding claim 24, Smith in view of Phillips suggests the invention of claim 1. The combination further discloses wherein the container 100 (Fig. 1 of Smith) is formed of a plastic (Par. 13 of Smith – “The cup 100 can be composed of plastic”).
However, the combination does not disclose a plastic selected from the group consisting of polyethylene (PE) including high-density polyethylene (HDPE) and low-density polyethylene (LDPE), polyvinyl chloride (PVC), polypropylene (PP), nylon, polyterpthalate (PET), polycarbonate, cyclic olefin copolymers (COC), polystyrene, and a combination thereof.
Gosau, in the same field of endeavor of in the same field of endeavor of administration system for drug combinations (Title), teaches wherein the container 12 (Fig. 1a – outer shell 12) is formed of a plastic of polyvinyl chloride (PVC) (Claim 7 – “ wherein said outer shell includes at least one material selected from the group consisting of… polyvinyl chloride…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the container of the combination to have it formed of polyvinyl chloride as taught by Gosau, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the container of the combination out of polyvinyl chloride as taught by Gosau, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of drug administration system. Modifying the combination’s container to have a polyvinyl chloride container would not change the device’s function of containing a drug.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Phillips as applied to claim 1 above, and further in view of Rousseau et al. US 6,255,101 B1 (previously cited, hereinafter Rousseau).
Regarding claim 27, Smith in view of Phillips suggests the invention of claim 1. The combination does not disclose further discloses wherein the container comprises an inner protrusion allowing the self-dispersible dry pharmaceutical composition to be held in place.
Rousseau, in the same field of endeavor of packaging of reagents ready for use or even freeze-dried reagents intended to be restored prior to use with a solvent and/or a diluting agent, such as distilled water (Col. 1, line 8-11), teaches wherein the container 1 (Fig. 1 – flask 1) comprises an inner protrusion 9 (Fig. 1 – ribbing 9) allowing the self-dispersible dry pharmaceutical composition to be held in place (Col. 2, line 29-30 – “This ribbing 9 is used to retain the freeze-dried reagent cake 10…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the container of the combination to further have an inner protrusion as taught by Rousseau, in order to retain the freeze-dried component (Col. 2, line 29-30 of Rousseau).
Regarding claim 28, Smith in view of Phillips in view of Rousseau suggests the invention of claim 27. The combination further discloses wherein the inner protrusion 9 (Fig. 1 of Rousseau) is a circumferential protrusion (Fig. 1 of Rousseau and Col. 2, line 26-27 of Rousseau – “a re-entering circular ribbing 9”).
Examiner notes that once the modification is made as discussed in claim 27, the inner protrusion 9 of Rousseau will be incorporated into the container of the combination, including it being circumferential. Thus, the limitation is met.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Phillips as applied to claim 1 above, and further in view of Mahoney et al. US 2016/0009429 A1 (previously cited, hereinafter Mahoney).
Regarding claim 30, Smith in view of Phillips suggests the invention of claim 1. The combination does not explicitly disclose wherein the seal cover comprises product information.
Mahoney, in the same field of endeavor of single serve containers (Par. 2), teaches wherein the seal cover 16 (Fig. 1 – lid 16) comprises product information (Par. 4 – “Printing the upper surface 24 with the contents and/or brand name and sealing the cup with a lid that has been printed…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the seal cover of the combination to further have product information as taught by Mahoney, as it is well-known that printing the lid and sealing a container with said lid allows for extended period of shelf time and allows large quantities of cups to be stored until they are ready for shipment (Par. 4 of Mahoney). Furthermore, it is well-known in the pharmaceutical art that packages require detailed labeling for manufacturers, distributers, and consumers to keep track of the medication that is being use for treatment.
Regarding claim 31, Smith in view of Phillips in view of Mahoney suggests the invention of claim 30. The combination further discloses wherein the product information comprises a product name (Par. 4 of Mahoney – “Printing the upper surface 24 with the contents and/or brand name and sealing the cup with a lid that has been printed…”).
Examiner notes that once the combination is made as discussed in claim 30, the printed product information onto the seal cover of the combined device will be the brand/product name as taught by Mahoney. Thus, the limitation is met.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Phillips as applied to claim 1 above, and further in view of Stein et al. US 2017/0225879 A1 (previously cited, hereinafter Stein).
Regarding claim 34, Smith in view of Phillips suggests the invention of claim 1. The combination does not disclose further discloses wherein a seal contact to secure the seal cover to the container is provided by an adhesive.
Stein, in the same field of endeavor of dry powder mix and serving unit (Par. 3), teaches wherein a seal contact to secure the seal cover to the container is provided by an adhesive (Par. 69 of Stein – “the seal 120 includes a metallic (e.g., aluminum) foil sheet bonded to the rim 113 of the cup 110 with… a food-safe adhesive”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the container of the combination to further have it seal to the container via adhesive as taught by Stein, in order to prevent liquid from escaping the container during a processing cycle (Par. 70 of Stein) and enclose and seal the dry powder mix within the container until further processing (Par. 41 of Stein).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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