DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 11/11/2025.
Claims 94-95, 97, 99-101, and 103 are pending and are examined on the merit.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 94-95, 97, 99-101, and 103 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 94 and 103 are amended to recite that “….wherein the chewable gel product is an aqueous hydrogel”. Recourse to the entire specification, no disclosure of chewable gel product is an aqueous hydrogel”. To the contrary, the specification discloses use of some oils in the claimed composition.
If applicant contends there is support for this limitation, then applicant is requested to specify the page and line of said support. In accordance to MPEP 714.02, applicant should specifically point out to where in the disclosure a support for any amendment made to the claims can be found.
The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to one skilled in the art that the inventor had the possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claimed language. See In re Kaslow, 707 F 2d 1366, 1375 (Fed. Cir. 1983). See MPEP 2163.06.
The written description requirement prevents applications from using the amendment process to update the disclosure in their disclosures (claims or specification) during the pendency before the patent office. Otherwise applicants could add new matter to their disclosures and date them back to their original filing date, thus defeating an accurate accounting of the priority of the invention. See 35 USC 132. The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genetech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 94-95, 97, 99-101 and 103 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Westhusing et al. (US 2016/0067180, IDS filed 12/13/2021), Jin et al. (US 2007/0128285, IDS filed 12/13/2021), Seternes et al. (US 2011/0268771, IDS filed 12/13/2021), the article by Jade et al. (“Co-processed k-carrageenan-pectin pelletizing aid for immediate-release pellets”, previously provided), and Siwek (US 2014/0065192, IDS filed 12/13/2021).
Applicant Claims
Claim 94 is directed to a method for producing a chewable gel product, comprising:
formulating a liquid composition comprising
a gel carrier comprising a combination of water, carrageenan and pectin or a combination of carrageenan and gelatin, and
- an active pharmaceutical ingredients elected from the group consisting of loratadine, diphenhydramine, desloratadine, phenylephrine, chlorpheniramine, dextromethorphan, doxylamine, guaifenesin, fexofenadine, docusate, pseudoephedrine, cetirizine, triprolidine, brompheniramine, ephedrine, ibuprofen, acetaminophen (paracetamol), ketoprofen, naproxen, piroxicam, meloxicam, leflunomide, carbamazepine, lamotrigine, clozapine, olanzapine, risperidone, citalopram, paroxetine, sertraline, fluoxetine, fluvoxamine, zopiclon, zolpidem, cimetidine, ranitidine, omeprazole, metoclopramide, cisapride, domperidon, zafirlukast, montelukast, pramipexol, selegiline, doxazosin, terazosin, atenolol, bisoprolol, amlodipine, nifedipine, diltiazem, enalapril, captopril, ramipril, losartan, glyceroltrinitrate, alfuzosin, finasteride, pravastatin, atorvastatin, simvastatin, gemfibrozil, metformin, terfenadine, celecoxib, rifecoxib, rivastignine, astemizole, hydroxyzine, clemastine, local anesthestics, antiseptics, opioids, opioid derivatives, sildenafil, tadalafil, vardenafil, and a pharmaceutically acceptable salt, ester, hydrate or solvate thereof;
b. adjusting the pH of the liquid composition to a pH that ranges from about 2.5 to about 8; and
c. gelating the liquid composition at a temperature sufficient to yield a chewable gel product, wherein the chewable gel product comprises 1-3 wt.% a combination of carrageenan and pectin or a combination of carrageenan and gelatin wherein the water content of the chewable gel product is between about 5-25% w/w, and wherein the chewable gel product is an aqueous hydrogel.
Claims 103 is directed to a product made by the process of:
formulating a liquid composition comprising
a gel carrier comprising combination of water, carrageenan and pectin or a combination of water, carrageenan and gelatin, and an active pharmaceutical ingredient selected from the group consisting of loratadine, diphenhydramine, desloratadine, phenylephrine, chlorpheniramine, dextromethorphan, doxylamine, guaifenesin, fexofenadine, docusate, pseudoephedrine, cetirizine, triprolidine, brompheniramine, ephedrine, ibuprofen, acetaminophen (paracetamol), ketoprofen, naproxen, piroxicam, meloxicam, leflunomide, carbamazepine lamotrigine, clozapine, olanzapine, risperidone, citalopram, paroxetine, sertraline, fluoxetine, fluvoxamine, zopiclon, zolpidem, cimetidine, ranitidine, omeprazole, metoclopramide, cisapride, domperidon, zafirlukast, montelukast, pramipexol, selegiline, doxazosin, terazosin, atenolol, bisoprolol, amlodipine, nifedipine, diltiazem, enalapril, captopril, ramipril, losartan, glyceroltrinitrate, alfuzosin, finasteride, pravastatin, atorvastatin, simvastatin, gemfibrozil, metformin, terfenadine, celecoxib, rifecoxib, rivastignine, astemizole, hydroxyzine, clemastine, local anesthestics, antiseptics, opioids, opioid derivatives, sildenafil, tadalafil, vardenafil, and a pharmaceutically acceptable salt, ester, hydrate or solvate thereof;
adjusting the pH of the liquid composition to a pH that ranges from about 2.5 to about 8; and
gelating the liquid composition at a temperature sufficient to yield a chewable gel product, wherein the chewable gel product comprises 1-3 wt.% a combination of carrageenan and pectin or a combination of carrageenan and gelatin,
wherein the water content in the chewable gel product is between about 5-25 % w/w, and wherein the chewable gel product is an aqueous hydrogel.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Westhusing teaches chewable dosage form that contains an active pharmaceutical ingredient, a gelling agent, gelatin, water and a pH adjusting agent (abstract; ¶¶ 0007-0008, 0019, 0060, 0096, 0097, 0149-056). The gelling agent includes pectin. The reference teaches and exemplifies combination of pectin and gelatin (¶¶ 0006-0009, 0067-0073, 0096-0097, 0209, 0227; claims 1 and 2). The reference discloses process of making the chewable dosage form comprising the step of mixing active ingredient and gelling agent to a liquid composition, mixing pH adjusting agent, solidifying the mix to the final product by cooling (¶¶ 0199-0202). The consistency of the semi-solid dosage form is the same as or similar pectin-based candy products such as, for example, gummy bears and pectin jellies and suitable for oral administration without an unpleasant taste or problem with swallowing to improve patient compliance (¶¶ 0005, 0015). The pharmaceutical ingredient includes loratadine, dextromethorphan, pseudoephedrine, and diphenhydramine (¶¶ 0009, 0037, 0149; table 1; examples). The dosage form comprises 0.5-7% gelling agent, e.g. pectin, 8 to about 15% of water, and 0.01-10% active agent (¶¶ 0067-0073, 0096-0107, 0122, 0156; examples). The pH adjusting agent includes citric acid and ascorbic acid (¶ 0084; examples). The pH adjusting agent is used to adjust the pH of the dosage form to 4-6, and preferably from 4.5-5.5 (¶¶ 0196- 0198; examples).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012) &
While Westhusing suggests combination of pectin and gelatin, the reference does not teaches combination of pectin with carrageenan as claimed by claims 94 and 95 or combination of gelatin with carrageenan as claimed by claims 94 and 97.
Jin teaches jellied pharmaceutical for oral administration of active agent the composition comprises combination of two or more gelatinizing agent comprising carrageenan, pectin, and gelatin, and water (abstract; ¶¶ 0015, 0055; claims 1-4). Examples 16-29 teach composition comprise combination of carrageenan and pectin. The amount of the gelatinizing agent is from 0.01-7% of the jellied composition, and preferably 0.1-3% (¶¶ 0023-0025). The pH of the composition is from 3.0 to 7.0 (¶ 0030). The jellied pharmaceutical composition having ensured preservation stabilities, good flavor, and good smoothness in throat so it can prevent side effects (retching/vomiting) in patient with dry mouth (¶¶ 0008-0010). The composition comprises buffer to maintain the desired pH including citric acid (¶ 0032).
Seternes teaches a soft, chewable gelled oral dosage form for delivering active agents (title; abstract; ¶¶ 0009-0013; claims 1-4). Particular preferred drugs to be deliver by the chewable gel dosage form include dextromethorphan, loratadine, pseudoephedrine, and diphenhydramine (¶¶ 0019, 0020). The chewable gel oral dosage form comprises gelling agent comprising mixture of gelatin and polysaccharide, e.g. carrageenan and pectin. The gelatin is present in amount of 1-50%, preferably 2-5%, and polysaccharide is present in amount of 0.01-5%, preferably 0.1-1.5% (¶¶ 0030- 0037). The chewable dosage form further comprises pH modifier to provide pH of the aqueous phase is between 3-7.5 (¶¶ 0038-0039). Examples 1 and 2 teach method of making the gelled chewable dosage form comprising mixing water, gelling, agent and citric acid and drug. The mixture is gelled to form the final dosage form (¶ 0049).
Jade teaches combination of carrageenan and pectin to produce immediate release oral formulation that is complete and fast dissolving (see the entire document, and in particular the abstract and conclusion).
Siwek teaches chewable gelled dosage form that is soft and has sour acceptable
taste to avoid the risk of patient non-compliance (abstract; ¶¶ 0001, 0002, 0035). The
chewable gelled composition is suitable to deliver loratadine (¶ 0033). The dosage form
comprises gelling agents, and preferred gelling agents are carrageen, pectin, and gelatin and their mixture (¶ 0017; claims 8, 9).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to produce chewable dosage form for delivering active agents wherein the chewable dosage form comprises gelling agent comprising mixture of pectin and gelatin by the process taught by Westhusing, and use gelling agents comprising pectin and carrageenan or gelatin and carrageenan as taught by Jin. One would have been motivated to do so because Jin teaches gelled composition comprising such mixture of gelling agents is preferred and ensured preservation stabilities, good flavor, and good smoothness in throat so it can prevent side effects (retching/vomiting) in patient with dry mouth. One would reasonably expect producing chewable gelled oral dosage comprising a mixture of carrageenan and pectin or carrageenan and gelatin wherein the composition is stable, acceptable and palatable to the user.
Further, one having ordinary skill in the art would have used a mixture of carrageen and pectin taught by Seternes or Jade in the dosage form taught by combination of Westhusing and Jin because Seternes suggests their combination in soft gelled dosage form, and because Jade teaches the combination of carrageenan and pectin produces immediate release oral formulation that is complete and fast dissolving.
Furthermore, one having ordinary skill in the art would have used a mixture of carrageen and pectin taught by Siwek in the dosage form taught by combination of Westhusing and Jin because Siwek teaches the combination of carrageenan and gelatin produces soft dosage form having acceptable sour taste therefore improves patient compliance.
Regarding the amount of gelling agent of 1-3 wt.% as claimed by claims 94 and 103, Westhusing teaches 0.5-7% gelling agent, and Jin teaches 0.01-7%, and preferably 0.1-3% of gelling agent in the jellified composition. Therefore, the claimed amount overlaps with that taught by the prior art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the three steps claimed by claims 94 and 103, Westhusing and Seternes teach a) formulating liquid composition, b) adjusting PH that is implied by adding pH modifier to adjust the pH to the claimed pH using citric acid, and c) gelling the composition.
Regarding the pH claimed by claim 94, 101 and 103, the claims recite 2.5-8 and 2.5-4, respectively, and Westhusing teaches 4-6, Seternes teaches 3-7.5 and Jin teaches pH of 3-7. The pH taught by the prior art that falls within the pH claimed by claim 94, and overlaps with the pH claimed by claim 101. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the combination of carrageenan and pectin as claimed by claims 94 95, and 103, this is taught and suggested by the combination of the cited references.
Regarding the combination of carrageenan and gelatin as claimed by claims 94 and 97, this is taught and suggested by combination of the cited references.
Regarding the amount of water between 5 and 25% as claimed by claims 94 and 103, Westhusing teaches 8-15% water that falls within the claimed amount. . In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the limitation of claims 94 and 103 that “the chewable gel product is an aqueous hydrogel”, Westhusing teaches gelling agent and water in the composition, and Jin teaches composition comprising carrageenan, pectin, and water; and further combination of the cited references teaches the claimed method of making the claimed composition comprising the claimed ingredients including gelling agents and water in the claimed amounts, and the presence of the claimed gelling agents with water are expected to form hydrogel as claimed, absent evidence to the contrary. The gel taught by the cited references is the same claimed gel and expected to absorb water and form hydrogel since materials and their properties are inseparable.
Regarding acid claimed by claims 99 and 100, the cited references teach the claimed citric acid, in particular Westhusing, Jin and Seternes.
Regarding the drugs claimed by claims 94 and 103, Westhusing, Jin, Seternes and Siwek teach the claimed drugs including loratadine, dextromethorphan, pseudoephedrine, and diphenhydramine.
Regarding the product produced by the claimed process as claimed by claim 103, it is taught by the combination of the cited references.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 94, 95, 97, 99-101, and 103 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-4, 6-11 of copending Application No. 18/392,417 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on the copending application since the referenced copending application and the instant application are claiming common subject matter as follows: a method for producing a chewable gel product, comprising: formulating a liquid composition comprising a gel carrier, water, and an active pharmaceutical ingredient, wherein the gel carrier comprises carrageenan, pectin, gelatin, and any combination thereof, and; gelating the liquid composition at a temperature sufficient to yield a chewable gel product. The amount of claimed ingredients in both applications are the same or overlapping. The gel claimed by the copending application expected to absorb water and form hydrogel since materials and their properties are inseparable. The present claims anticipate the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive.
Claim Rejections — 35 U.S.C. §103
Applicants argue that amended independent claims 94 and 103 recite that the claimed chewable gel product is an aqueous hydrogel. This amendment crystallizes the fundamental structural difference between Applicant's invention and the emulsion-based systems of the primary references, Seternes and Siwek.
In response to this argument, it is argued that the claimed aqueous hydrogel is taught by the primary reference Westhusing. Westhusing teaches gelling agent and water in the composition, and Jin teaches composition comprising carrageenan, pectin, and water; and further combination of the cited references teaches the claimed method of making the claimed composition comprising the claimed gelling agents in the claimed amounts, and water, and the presence of the claimed gelling agents with water are expected to form hydrogel as claimed, absent evidence to the contrary. Seternes is relied upon for solely teaching mixture of carrageen and pectin they can be combined in soft gelled dosage form. Siwek is relied upon for solely teaching combination of carrageenan and gelatin to produce soft dosage form having acceptable sour taste therefore improves patient compliance.
Applicants argue that the claimed combination is improper, as the references teach away from one another and their combination would be structurally inoperable.
In response to this argument, it is argued that, as stated above, Seternes and Siwek are relied upon for teaching combination of gelling agents for the benefits set forth in this office action, and the references satisfy the purpose for which they were applied. The cited references are analogous art and in the field of the inventor’s endeavor or reasonably pertinent to the particular problem with which the inventor was concerned that is forming chewable tablets, therefore, it is proper to be relied upon as a basis for rejection of the claimed invention. The references do not teach away from each other or from using the claimed gelling agent in oral dosage forms. "A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. The degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant." In re Gurley, 27 F.3d 551,553 (Fed. Cir. 1994). A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984).
Applicants Argue The Claimed Aqueous Hydrogel is Structurally Incompatible with the Emulsion-Based Prior Art
Applicants argue that the amended claims now explicitly define the chewable gel product as an aqueous hydrogel. An aqueous hydrogel is a three-dimensional network of hydrophilic polymer chains swollen with water, forming a single continuous aqueous phase. The present specification provides ample support for this limitation. The gelling agents (pectin, carrageenan, gelatin) are hydrophilic polymers, and all exemplified formulations are water-based systems containing water-soluble base vehicles like sucrose and maltitol, and are devoid of any bulk oil phase or primary emulsifying agents needed to form an emulsion. Even where a trace amount of oil is mentioned in Table 10, the specification clarifies its purpose is as an external "anti-sticking agent that also provides a glossy coating" (Current Application, para. [0122]), not as an internal, emulsified component.
In response to this argument, it is argued that Westhusing teaches gelling agent and water in the chewable composition, and Jin teaches composition comprising carrageenan, pectin, and water in the chewable tablet; and further combination of the cited references teaches the claimed method of making the claimed composition comprising the claimed gelling agents in the claimed amounts, and the presence of the claimed gelling agents with water are expected to form hydrogel as claimed, absent evidence to the contrary. The gel taught by the cited references is the same claimed gel and expected to absorb water and form hydrogel since materials and their properties are inseparable.
Regarding paragraph [0122], the paragraph states the following:
In Table 10, the MCT coconut oil with carnauba wax is used as an anti-sticking agent that also provides a glossy coating to the product. The MCT coconut oil with carnauba wax is a blend of coconut oil and carnauba wax.
The paragraph admits presence of oils in the composition without disclosing any amounts in the composition. No disclosure of aqueous hydrogel in the present application. Therefore, the oil taught by the prior art reads on the claims, especially in view of the expression “comprising” of the claims language.
It is reiterated that aqueous compositions comprising gelling agents are taught by Westhusing and Jin, and the references that teach emulsions are relied upon for solely showing that the claimed gelling agents and their combination were known in the art before the effective filing date in the present invention.
Combination of cited references as utilized in the rejection, is adopting the gelling agents from the secondary references, including carrageenan, gelatin and pectin in different combination, and not adopting any emulsion from these references.
Applicants argue that, in stark contrast, the primary reference, Seternes, is directed to solving the problem of poor bioavailability for lipophilic (oil-soluble) drugs. The entire technical framework of Seternes is built around a "gelled oil-in-water emulsion" (Seternes, para. [0006], Claim 1). Likewise, Siwek is explicitly directed to an "oil-in-water emulsion" to mask the taste of oil (Siwek, Abstract). In these references, the oil phase is an essential structural component for carrying the active agent or is the source of the problem being solved.
In response to this argument, applicant’s attention is directed to Seternes reference that it is not the primary references. It is reiterated that Westhusing is the primary reference that teaches composition comprising gelling agent and water. Seternes is relied upon for solely teaching mixture of carrageenan and pectin that can be combined in soft gelled dosage form. Siwek is relied upon for solely teaching combination of carrageenan and gelatin to produce soft dosage form having acceptable sour taste therefore improves patient compliance. Regardless of the presence of an oil phase in Seternes and Siwek references as essential element, the rejection is not based on adopting the phases of the composition to the teachings of Westhusing, only adopting combination of gelling agents. In considering the disclosure of the reference, it is proper to take into account not only the specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom. In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). The rational to modify or to combine the prior art does not have to be expressly stated in the prior art; the rational may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve different problem. It is not necessary that the prior art suggest the combination or modification to achieve the same advantage or result discovered by applicant. In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972).
Applicants argue that a person of ordinary skill in the art (POSA) starting with the oil-in-water emulsion of Seternes could not arrive at the claimed aqueous hydrogel. To do so would require removing the essential oil phase and emulsifiers, thereby destroying the fundamental structure of the Seternes invention and rendering it inoperable for its stated purpose of delivering a lipophilic drug. The teachings of Jin and Westhusing, which describe simple aqueous gels, are therefore structurally incompatible with and teach away from the emulsion-based framework of Seternes and Siwek. It would not have been obvious to combine these references in a way that defeats the primary reference's core purpose.
In response to this argument, it is argued that all the steps and ingredients of the claimed method, and product by process claims are taught by combination of the cited references. Motivation to combine the references exists, even if different from what applicants had done, and reasonable expectation to achieve the present invention has been presented, as set forth in this office action. The position taken regarding Seternes and Siwek references is hereby repeated and maintained. A conclusion of obviousness does not require absolute predictability, only reasonable expectation of the success. References are evaluated with what they have suggested to one having ordinary skill in the art and not by their own disclosure. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
Applicants argue that the problem solved by Applicant's invention-the acid-induced bitterness of loratadine in an aqueous system (Current Application, para. [0004]) - is not recognized by any of the cited art. A POSA would not be motivated to abandon the emulsion system of Seternes to create an aqueous hydrogel, as there is no teaching in the prior art that doing so would solve this specific, unrecognized problem. The amended claims now clearly define a structure that is fundamentally different from and incompatible with the teachings of the primary references. The proposed combination is therefore improper.
In response to this argument, it is argued that, it should be noted that motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references and achieve the present invention as set forth in this office action. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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, motivation to combine the references exists, as well as reasonable expectation to achieve the present invention as set forth in this office action. Finally, the obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Applicants argue that dependent claims 95, 97, and 99-101 incorporate all the limitations of allowable independent claim 94 and are therefore also in condition for allowance.
In response to this argument it is argued that claims 94 and 103 are not allowable for all the reasons set forth in this office action. All the limitations of dependents claims are taught either explicitly or implicitly by the cited references as explained in the above rejection, therefor not allowable.
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 Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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, Bethany Barham can be reached on 571-272-6175. 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.
/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./