Prosecution Insights
Last updated: April 19, 2026
Application No. 18/205,337

METHODS AND APPARATUS FOR DISPENSING A THERAPEUTIC AGENT

Non-Final OA §103§112
Filed
Jun 02, 2023
Examiner
MENDEZ, MANUEL A
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Papeltec Overseas Inc.
OA Round
1 (Non-Final)
86%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
94%
With Interview

Examiner Intelligence

Grants 86% — above average
86%
Career Allow Rate
1040 granted / 1207 resolved
+16.2% vs TC avg
Moderate +8% lift
Without
With
+8.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
40 currently pending
Career history
1247
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
44.4%
+4.4% vs TC avg
§102
24.0%
-16.0% vs TC avg
§112
12.4%
-27.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1207 resolved cases

Office Action

§103 §112
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 . Specification The disclosure is objected to because of the following informalities: in the specification, paragraphs [0016], [0027], [0036], and [0047], disclose the word “silicon”. It appears that the word “silicon” is misspelled and should be replaced with the word - - silicone - -. Silicon (Si) is a chemical element (atomic number 14), which is a hard, brittle crystalline solid. It is not an "elastic" material and would not be suitable for a "compressible" or "chewable" element as described in the invention. Silicone, on the other hand, is a class of synthetic polymers that are known for being flexible, elastic, and nontoxic. These properties are consistent with the description of the compressible element in the disclosure. 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. 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 9 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. The claim recites that the "elastic, nontoxic material is silicon". The use of the term "silicon" renders the claim indefinite because, in the context of the invention, it is unclear what material is being claimed. The specification describes a "compressible element" (see paragraph [0007]) with a "chewable surface" (see paragraph [0006] made of an "elastic, nontoxic material" (see paragraph [0007]). However, Silicon is a chemical element (atomic number 14), which is a hard, brittle crystalline solid. It is not an "elastic" material and would not be suitable for a "compressible" or "chewable" element as described in the invention. Silicone, on the other hand, is a class of synthetic polymers that are known for being flexible, elastic, and nontoxic. These properties are consistent with the description of the compressible element in the disclosure. Given the properties described for the material throughout the specification and parent claim 8, the use of "silicon" in claim 9 is reasonably interpreted as a typographical error for "silicone." As written, the claim is indefinite because it specifies a material that does not possess the properties required by the claim language and the overall disclosure, leaving one to guess as to the intended meaning. Examiner’s Comment During the initial search of this application, the examiner located a PCT search with a written opinion completed by the U.S. Patent and Trademark Office [as the international searching authority] on September 18, 2023. Importantly, the claims rejected in the written opinion are exactly the same ones as the claims filed in this application. The written opinion in question was not cited on the Information Disclosure Statement (IDS) filed on 1/3/2024. The examiner of record has included a copy of the written opinion and the respective search strategy in the PTO-892 [Notice of References Cited] for review by Applicant. The examiner of record reviewed the rejections and concluded that said rejections are sound and reasonable. Therefore, the examiner of record requests Applicant to consider the following rejections and provide a formal response. IP.COM translations of all the foreign documents cited in the office action have been incorporated to this office action to facilitate the review of the foreign documents. 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. Claims 1, 2, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”). In relation to independent claim 1, CROWE discloses a dispensing device for dispensing an ingestible material (a medicine administering unit, a compressible fluid dispenser; abstract), comprising: a compressible element including (compressible fluid dispenser; abstract): a compressible pouch for containing the ingestible material (compressible fluid dispenser; bulb (compressible pouch) is attachable with respect to body and is prefilled with medicinal or other fluid material; abstract, claim 10); a flexible surface for oral use (a flexible nipple having an inlet and a sucking orifice; abstract); and at least one valve between the compressible pouch and the flexible surface for oral use (valve in fluid outlet adapted to allow fluid flow from said bulb (compressible pouch) though bore and into nipple (flexible surface) upon compression; claim 26), the at least one valve configured to prevent flow of the ingestible material when the compressible element is in an uncompressed state (a normally closed sealable valve 39 which is adapted to become opened only by significantly pressurizing bulb 26; fig. 3, column 3 lines 59-62), and dispense the ingestible material when pressure is applied to the flexible surface for oral use (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple (pressure is applied); column 4 lines 19-22). CROWE does not disclose a chewable surface. PNG media_image1.png 336 684 media_image1.png Greyscale NEMOTO discloses a chewable surface (dental care stuffed toy (1) for a pet [see figure 1]; when the pet bites the stuffed animal, the liquid medicine oozes out; abstract, page 3 paragraph 7 of the original Japanese cited document). From the IP.com translation, on page 3, the fourth paragraph states: PNG media_image2.png 52 886 media_image2.png Greyscale Additionally, on page 3, the sixth paragraph of the IP.com translation states: PNG media_image3.png 88 874 media_image3.png Greyscale Based on the above teachings, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. In relation to claim 2, CROWE and NEMOTO, in combination, disclose the dispensing device of claim 1, and CROWE further discloses wherein the compressible element is configured such that the pressure applied to the flexible surface for oral use applies a pressure on the compressible pouch, thereby providing force to expel the ingestible material through the at least one valve (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple; placing reservoir (compressible element) in fluid communication with sucking orifice whereby fluid initially in the reservoir may be administered by the baby sucking on the nipple, wherein pressure responsive valve is provided within said passage whereby fluid in said reservoir is caused lo flow through said valve and out of said sucking orifice; column 4 lines 19-22, claim 17). CROWE does not disclose a chewable surface. NEMOTO discloses a chewable surface (dental care stuffed toy for a pet; when the pet bites the stuffed animal, the liquid medicine oozes out; abstract, page 3 paragraph 7). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. In relation to claim 6, CROWE and NEMOTO, in combination, disclose the dispensing device according to claim 1, and CROWE further discloses wherein the ingestible material is a therapeutic agent (a means for administering medicines; column 1, line 41). Since these enhancements were considered well-known in the art at the time of filing, their implementation in the invention would have been considered obvious alternatives in the design of the device. Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), as discussed above, and in further view of Toppan (JP2008064133A; hereinafter “TOPPAN”). In relation to claim 3, CROWE and NEMOTO, in combination, disclose the dispensing device according to claim 1, and CROWE discloses where pressure is applied to the flexible surface for oral use (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple; column 4 lines 19-22). CROWE does not disclose wherein the at least one valve is an alignment valve including two channels; and the alignment valve is configured such that the two channels are in an unaligned state when the compressible element is in the uncompressed state, and the two channels move into alignment when the pressure is applied to the flexible surface, or a chewable surface. TOPPAN discloses wherein the at least one valve is an alignment valve including two channels (a valve; a first and second elastic conduit capable of elastic deformation A1 and A3; two second pipes that connect the first two pipes facing each other, C1 to C3 and 01 to 03; fig. 1 shows that when shaft Eis at its highest position, flow path A1 to A3 is occluded, but when shaft Eis compressed downward, the connecting flow paths C1 to C3 and D1 to D3 are compressed, but the elastic conduit tube circumference path A1 to A3 is now aligned, allowing flow along the A1 to A3 path; abstract, claim 1, fig. 1); and the alignment valve is configured such that the two channels are in an unaligned state when the valve is in the uncompressed state (fig. 1 shows that when shaft Eis at its highest position, flow path A1 to A3 is blocked by compression to the flexible elastic conduits, causing the flexible tube circumference where A 1 meets A3 to be in an unaligned state; fig. 38 shows shaft E2 blocking the A conduit; claim 1, figs. 1, 38), and the two channels move into alignment when the pressure is applied to the valve (fig. 1 shows that when shaft E is compressed to its lowest position, flow path A 1 to A3 is uncompressed and the flexible tube circumference is aligned; fig. 1). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the at least one valve is an alignment valve including two channels; and the alignment valve is configured such that the two channels are in an unaligned state when the compressible element is in the uncompressed state, and the two channels move into alignment when the pressure is applied to the flexible surface, as taught by TOPPAN, because this will allow fluid flow through the two channels only when pressure is placed upon the valve and the fluid will not drip out when no pressure is applied. NEMOTO discloses a chewable surface (dental care stuffed toy for a pet; when the pet bites the stuffed animal, the liquid medicine oozes out; abstract, page 3 paragraph 7). lt would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. In relation to claim 4, CROWE, NEMOTO, and TOPPAN, in combination, disclose the dispensing device according to claim 3, and modified CROWE discloses where pressure is applied to the flexible surface for oral use (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple (pressure is applied); column 4 lines 19-22) and NEMOTO discloses a chewable surface (dental care stuffed toy for a pet; the pet bites the stuffed animal; abstract, page 3 paragraph 7). CROWE does not disclose wherein the alignment of the two channels of the alignment valve increases with increasing pressure applied to the valve. TOPPAN discloses wherein the alignment of the two channels of the alignment valve increases with increasing pressure applied to the valve (fig. 1 shows that when shaft E is at its highest position, flow path A1 to A3 is blocked by compression to the flexible elastic conduits, causing an unaligned state in the elastic conduit tube circumference between A1 and A3, but as shaft E is compressed downward, flow path A1 to A3 will gradually become open as the flexible conduit tubes become aligned, as the compressive blocking force from shaft E2 is removed from the flow path, allowing increasing alignment of A1 to A3 with increasing pressure from the shaft E and E2; claim 1, fig. 1 ). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the alignment of the two channels of the alignment valve increases with increasing pressure applied to the valve, as taught by TOPPAN, because this will allow control of the flow rate of the liquid based on the force pressed on the valve. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), as discussed above, and in further view of Yingkou Chengyuan Machinery Equipment Co. LTD (CN215172487; hereinafter “YINGKOU”). In relation to claim 5, CROWE and NEMOTO, in combination, disclose the dispensing device according to claim 1, and CROWE further discloses wherein: the at least one valve is closed (non-communicative) when no pressure is applied to the flexible surface for oral use (a normally closed sealable valve 39 which is adapted to become opened only by significantly pressurizing bulb 26; medicine or other fluid in the nipple and reservoir may be administered by the baby sucking on the nipple; and so when no pressure is applied the valve is closed; column 3 lines 59-62, column 4 lines 19-22); and the pressure applied to the flexible surface for oral use forces the ingestible material through the at least one valve to the flexible surface (medicine or other fluid in the reservoir may be administered by the baby sucking on the nipple (flexible surface); valve comprises a pressure-rupturable membrane; pressure responsive valve whereby fluid in reservoir is caused to flow through said valve and out of sucking orifice upon pressurizing the fluid in said reservoir relative to the pressure in said nipple; column 4, lines 19-22, claims 12, 17). CROWE does not disclose wherein the at least one valve is a one-way valve; and a chewable surface. YINGKOU discloses a one-way valve (a tubular double one-way valve; abstract). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include a one-way valve, as taught by as taught by YINGKOU, because this design can ensure that fluid cannot flow back (YINGKOU; abstract) which could cause contamination. NEMOTO discloses a chewable surface (dental care stuffed toy for a pet; the pet bites the stuffed animal; abstract, page 3, paragraph 7). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), as discussed above, and in further view of Potnis et al. (WO2014087420A1; hereinafter “COLGATE-PALMOLIVE”). In relation to claim 7, CROWE and NEMOTO, in combination, disclose the dispensing device according to claim 1, but CROWE does not disclose wherein the ingestible material is a topical agent. COLGATE-PALMOLIVE discloses wherein the ingestible material is a topical agent (orally acceptable topical analgesic gel; abstract). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the ingestible material is a topical agent, as taught by COLGATE-PALMOLIVE, because the gel taught by COLGATE-PALMOLIVE provides an effective amount of the analgesic oils to the tooth after 30 seconds (COLGATE-PALMOLIVE; claim 2) and could be dispensed by the device of modified CROWE for relief of tooth pain. Claims 8-10, 13-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), as discussed above, and in further view of Kim Su Mi (KR20210040542A; hereinafter “KIM”). In relation to claim 8, CROWE and NEMOTO, in combination, disclose the dispensing device according to claim 1, and CROWE further discloses wherein the compressible element is made of an elastic material (the elastomeric nipple or bulb; column 3 line 50). CROWE does not disclose wherein the element is made of a nontoxic material. KIM discloses wherein the element is made of an elastic, nontoxic material (invention was made of a TPR resin material having a certain elasticity; the TPR resin is a non-toxic resin; page 2 paragraph 8, page 6 paragraph 2). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the compressible element is made of an elastic, nontoxic material, as taught by KIM, because KIM teaches a material that will not break when infants use the cup and which can be deformed and played with the force of the infant's hand (KIM; page 2 paragraph 8) and safe to put in an infant's mouth. In relation to claim 9, CROWE, NEMOTO, and KIM, in combination, disclose the dispensing device according to claim 8, and KIM further discloses wherein the elastic, nontoxic material is silicon (present invention is preferably a silicone rubber-based resin; page 6 paragraph 1). Since this enhancement was considered well-known in the art at the time of filing, its implementation in the invention would have been considered and obvious alternative in the design of the device. In relation to claim 10, CROWE, NEMOTO, and KIM, in combination, disclose the dispensing device according to claim 8, and KIM further discloses wherein the elastic, nontoxic material is a benign thermoplastic or nylon material (cup is made of a TPR, Thermo Plastic Rubber resin material; the TPR resin is a non-toxic resin and is hygienically safe (benign); page 5 paragraph 4, page 6 paragraph 2). Since these enhancements were considered well-known in the art at the time of filing, their implementation in the invention would have been considered obvious alternatives in the design of the device. In relation to independent claim 13, CROWE discloses a method for administering an ingestible material (a means for administering medicines to infants; column 1 lines 41-42), comprising: encasing the ingestible material in a compressible element made of an elastic material, and having a flexible surface for oral use (compressible fluid dispenser; the elastomeric nipple or bulb; medicine or other fluid in the bulb may be administered by the baby sucking on the nipple (applying pressure); bulb is attachable with respect to body and is prefilled with medicinal or other fluid material; abstract, column 3 line 50, column 4 lines 19-22, claim 10); and expelling the ingestible material to the flexible surface for oral use by applying pressure to the flexible surface (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple (applying pressure); placing reservoir (compressible element) in fluid communication with sucking orifice whereby fluid initially in the reservoir may be administered by the baby sucking on the nipple, wherein pressure responsive valve is provided within said passage whereby fluid in said reservoir is caused to flow through said valve and out of said sucking orifice; column 4 lines 19-22, claim 17). CROWE does not disclose containing the ingestible material in a compressible pouch; the compressible element being made of a nontoxic material; or a chewable surface. PNG media_image1.png 336 684 media_image1.png Greyscale As discussed in the analysis of independent claim 1, NEMOTO discloses containing the ingestible material in a compressible pouch. The liquid medicine is surrounded by a thin bag-like material in which holes are easily formed by pet teeth; the bag-like product is a thin product such as a vinyl product, and so the bag has flexible walls which can be punctured, contains a liquid, and thus is compressible. On page 6 of the IP.COM translation, the first and second paragraphs state: PNG media_image4.png 204 900 media_image4.png Greyscale Based on the above teachings, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include containing the ingestible material in a compressible pouch, as taught by NEMOTO, because this enhancement would have allowed the dispenser to be easily refilled by inserting a new pouch, and the dispenser can be used repeatedly (NEMOTO; IP.COM translation, page 3, paragraphs 2 and 7). NEMOTO further discloses a chewable surface (see figure 1; chewable surface (3)). Accordingly, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. Moreover, KIM discloses wherein the compressible element is made of an elastic (see IP.com translation, page 5, paragraph 12, second line), nontoxic material (invention was made of a TPR resin material having a certain elasticity; the TPR resin is a non-toxic resin; see IP.com translation, page 6, last paragraph). Accordingly, it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the compressible element is made of an elastic, nontoxic material, as taught by KIM, because KIM teaches a material that will not break when infants use the cup and which can be deformed and played with the force of the infant's hand (KIM; IP.com translation, page 4, paragraph 10… “the present invention was made of a TPR resin material having a certain elasticity so that infants do not break or break when using the cup. In addition, the infant cup made of TPR resin is used as a cup, and after use, it has a certain elasticity so that the cup can be deformed and played even with the force of the infant's hand”) and safe to put in an infant's mouth (KIM; IP.com translation, page 4, paragraph 9… “[t]he present invention is to provide an eco-friendly infant cup that is hygienically safe even if infants bite into their mouths or put them in their mouths when they use the cups”.) In relation to claim 14, CROWE, NEMOTO, and KIM, in combination, disclose the method according to claim 13, and CROWE further discloses wherein the ingestible material is a therapeutic agent (a means for administering medicines; column 1 line 41). In relation to claim 15, CROWE, NEMOTO, and KIM, in combination, disclose the method according to claim 14, and NEMOTO further discloses wherein the pressure is applied by chewing on the chewable surface (when the pet bites the stuffed animal 1, the liquid medicine 4 oozes out from the elastic absorber 3 and enters the oral cavity of the pet; page 4 paragraph 5). In relation to claim 20, CROWE, NEMOTO, and KIM, in combination, disclose the method of claim 14, and CROWE further disclose further comprising: discontinuing a flow of the ingestible material by discontinuing the application of pressure to the chewable surface (a normally closed sealable valve 39 which is adapted to become opened only by significantly pressurizing bulb 26; medicine or other fluid in the nipple and reservoir may be administered by the baby sucking on the nipple; and so the flow is discontinued when the pressure is discontinued; column 3 fines 59-62, column 4 fines 19-22). Since this process enhancement was considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the device. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), as discussed above, and in further view of Orubu et al. (the publication "Evaluating the Taste Masking Ability of Two Novel Dispersible Tablet Platforms Containing Zinc Sulfate and Paracetamol Reconstituted in a Breast Milk Substitute"; hereinafter “ORUBU”). In relation to claim 11, CROWE and NEMOTO, in combination, disclose the dispensing device according to claim 1, and CROWE further discloses the ingestible material (a medicine administering unit; abstract), but CROWE does not disclose wherein the compressible element and/or the ingestible material is flavored in a manner to which an intended user may be accustomed. ORUBU discloses wherein the ingestible material is flavored in a manner to which an intended user may be accustomed (the potential of infant formula milk Aptamil 1 to mask the taste of two model WHO priority medicines, zinc sulfate and paracetamol; Aptamil 1 masked the taste of zinc sulfate; and so medication was flavored with infant formula milk, a flavor for which an infant would be accustomed; abstract). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the ingestible material is flavored in a manner to which an intended user may be accustomed, as taught by ORUBU, because with very young children, palatability is paramount to adherence and effective clinical outcomes of medication administration (page 2 paragraph 3). In relation to claim 12, CROWE and NEMOTO, in combination, disclose the dispensing device according to claim 1, and CROWE further discloses the ingestible material (a medicine administering unit; abstract), but CROWE does not disclose wherein the ingestible material is flavored to emulate formula or mother's milk. ORUBU discloses wherein the ingestible material is flavored to emulate formula or mother's milk (the potential of infant formula milk Aptamil 1 to mask the taste of two model WHO priority medicines; Aptamil 1 masked the taste of zinc sulfate; and so medication was flavored with infant formula milk; abstract). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the ingestible material is flavored to emulate formula or mother's milk, as taught by ORUBU, because with very young children, palatability is paramount to adherence and effective clinical outcomes of medication administration (page 2 paragraph 3). Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), Kim Su Mi (KR20210040542A; hereinafter “KIM”), as discussed above, and in further view of Toppan (JP2008064133A; hereinafter “TOPPAN”). In relation to claim 16, CROWE, NEMOTO, and KIM, in combination, disclose the method according to claim 15, and CROWE discloses an amount of the ingestible material dispensed from the compressible pouch through the valve with pressure on the flexible surface for oral use (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple; placing reservoir (compressible pouch) in fluid communication with sucking orifice whereby fluid initially in the reservoir may be administered by the baby sucking on the nipple, wherein pressure responsive valve is provided within said passage whereby fluid in said reservoir is caused to flow through said valve and out of said sucking orifice; column 4 lines 19-22, claim 17). CROWE does not disclose wherein an amount of material dispensed from the valve increases with increased pressure on the valve, or a chewable surface. TOPPAN discloses wherein an amount of material dispensed from the valve increases with increased pressure on the valve (fig. 1 shows that when shaft Eis at its highest position, flow path A1 to A3 is blocked by compression to the flexible elastic conduits, causing an unaligned state to the conduit circumference for A1 and A3, but as shaft E is compressed downward, flow path A1 to A3 circumference will gradually become aligned and open as the compressive blocking force from shaft E2 is removed from the flow path, allowing increasing alignment of the circumference of A 1 to A3 with increasing pressure from the shaft E and E2 and allowing increasing flow as pressure increases; claim 1, fig. 1). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include wherein an amount of material dispensed from the valve increases with increased pressure on the valve, as taught by TOPPAN, because this will allow control of the flow rate of the liquid based on the force pressed on the valve. NEMOTO discloses a chewable surface (dental care stuffed toy for a pet; the pet bites the stuffed animal; abstract, page 3 paragraph 7). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), Kim Su Mi (KR20210040542A; hereinafter “KIM”), as discussed above, and in further view of Yingkou Chengyuan Machinery Equipment Co. LTD (CN215172487; hereinafter “YINGKOU”). In relation to claim 17, CROWE, NEMOTO, and KIM, in combination, disclose the method of claim 14, and CROWE further discloses wherein a valve is formed or encased in the compressible element between the compressible pouch and the flexible surface for oral use (a compressible fluid dispenser having an outlet mounted on opposite sides of the body with the inlet and the outlet being juxtaposed for fluid communication with each other thru a pressure openable valve whereby fluid in the dispenser can be injected under pressure into the nipple; valve comprises a simple pressure rupturable membrane 40; fig. 7 shows the valve between the bulb 26 and the nipple 22; abstract, fig. 7, column 4 lines 24-25) and applying the pressure to the flexible surface allows the ingestible material to flow through the valve (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple (applying the pressure); pressure-responsive valve means is provided whereby fluid in reservoir is caused to flow through said valve and out of sucking orifice upon pressurizing the fluid in the reservoir; column 4 lines 19-22, claim 17). CROWE does not disclose a chewable surface or more than one valve. NEMOTO discloses a chewable surface (dental care stuffed toy for a pet; the pet bites the stuffed animal; abstract, page 3 paragraph 7). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. YINGKOU discloses more than one valve (a tubular double one-way valve, a first one-way valve and a second one-way valve are sequentially arranged in an inner cavity of the valve body; abstract). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include more than one valve, as taught by YINGKOU, because this design can ensure that fluid cannot flow back (YINGKOU; abstract) which could cause contamination. In relation to claim 19, CROWE, NEMOTO, KIM, and YINGKOU, in combination, disclose the method of claim 17, and CROWE further discloses applying the pressure to the flexible surface for oral use increases a pressure on the ingestible material in the compressible pouch, thereby forcing the ingestible material through the valve to the flexible surface (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple; placing reservoir (compressible pouch) in fluid communication with sucking orifice whereby fluid initially in the reservoir may be administered by the baby sucking on the nipple, wherein pressure responsive valve is provided within said passage whereby fluid in said reservoir is caused to flow through said valve and out of said sucking orifice; column 4 lines 19-22, claim 17). CROWE does not disclose more than one valve, one-way valves, or a chewable surface. YINGKOU discloses wherein there are more than one valve and the valves are one-way valves (a double one-way valve, a first one-way valve and a second one-way valve are sequentially arranged in an inner cavity of the valve body; abstract). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include more than one valve, as taught by YINGKOU, because this design can ensure that fluid cannot flow back (YINGKOU; abstract) which could cause contamination. NEMOTO further discloses a chewable surface (dental care stuffed toy for a pet; the pet bites the stuffed animal; abstract, page 3 paragraph 7). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 5,772,685; hereinafter “CROWE”) in view of Nemoto et al. (JP2006230305A; hereinafter “NEMOTO”), Kim Su Mi (KR20210040542A; hereinafter “KIM”), Yingkou Chengyuan Machinery Equipment Co. LTD (CN215172487; hereinafter “YINGKOU”), as discussed above, and in further view of Toppan (JP2008064133A; hereinafter “TOPPAN”). As for claim 18, CROWE, NEMOTO, KIM, and YINGKOU, in combination, disclose the method of claim 17, and CROWE discloses applying pressure to the flexible surface for oral use to allow the flow of the ingestible material (medicine or other fluid in the bulb may be administered by the baby sucking on the nipple (applying the pressure); pressure responsive valve means is provided whereby fluid in reservoir is caused to flow through said valve and out of sucking orifice upon pressurizing the fluid in the reservoir; column 4 lines 19-22, claim 17). CROWE does not disclose a chewable surface, wherein the valve is an alignment valve including two channels, and applying the pressure to the valve moves the two channels of the alignment valves into alignment, thereby allowing the flow of the material; or more than one valve. NEMOTO discloses a chewable surface (dental care stuffed toy for a pet; the pet bites the stuffed animal; abstract, page 3 paragraph 7). It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include a chewable surface, as taught by NEMOTO, because this will allow a pet or child to self-dispense the medication while biting the surface of the device. TOPPAN discloses wherein the valve is an alignment valve including two channels (a valve; a first and second elastic conduit capable of elastic deformation A1 and A3; two second pipes that connect the first two pipes facing each other, C1 to C3 and D1 to D3; fig. 1 shows that when shaft Eis at its highest position, flow path A1 to A3 is occluded, but when shaft Eis compressed downward, the connecting flow paths C1 to C3 and D1 to D3 are compressed, but the elastic conduit tube circumference path A1 to A3 is now aligned, allowing flow along the A 1 to A3 path; abstract, claim 1, fig. 1 ); applying the pressure to the valve moves the two channels of the alignment valves into alignment, thereby allowing the flow of the material (fig. 1 shows that when shaft Eis at its highest position, flow path A1 to A3 is blocked by compression to the flexible elastic conduits by misaligning the circumferences of A1 and A3; when shaft Eis compressed to its lowest position, flow path A 1 to A3 is uncompressed and aligned, allowing flow along flow path A 1 to A3; claim 1, fig. 1 ).It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the device of CROWE to include wherein the valve is an alignment valve including two channels; applying the pressure to the valve moves the two channels of the alignment valves into alignment, thereby allowing the flow of the material, as taught by TOPPAN, because this will allow fluid flow through the two channels only when pressure is placed upon the valve and the fluid will not drip out when no pressure is applied. YINGKOU discloses more than one valve (a tubular double one-way valve, a first one-way valve and a second one-way valve are sequentially arranged in an inner cavity of the valve body; abstract). II would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of CROWE to include more than one valve, as taught by YINGKOU, because this design can ensure that fluid cannot flow back (YINGKOU; abstract) which could cause contamination. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM. 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, Bhisma Mehta can be reached at 571-272-3383. 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. Respectfully submitted, /MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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Prosecution Timeline

Jun 02, 2023
Application Filed
Jan 29, 2026
Non-Final Rejection — §103, §112 (current)

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