DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 02/11/2026; and IDS filed 03/19/2026.
Claims 2-4, 6-14 are pending.
Claim 14 has been withdrawn without traverse. However, the claim is incorrectly identified in the copy of claims received 02/11/2026 as (Previously Presented). Correction of the status of claim 4 is requested in the next communication.
Claims 1-4, 6-13 are subject of this office action.
Upon further review and consideration, a non-final office action is issued to address 35 USC § 112/d rejection of claim 4 that was not previously addressed unintentionally.
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 (a)
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 2-4, and 6-13 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.
Amended claim 2 recites “the composition is substantially free of an acid catalyst for gelation”. Applicants refers to paragraphs [0004], [0005] and [0025] for support. However review to these paragraphs and to the entire specification, applicants did not disclose any “acid catalysts” or any “acids used for gelation” that are eliminated from the claims. What are those acids that are eliminated from the claimed composition and method? Paragraph [0004] describes that some acids used with gelatin and pectin are not desired because they cause bitterness when combined with loratadine in a single composition. However, no specific acids are mentioned or enumerated that used to catalyze gelation to be excluded from the claimed composition and method. Further, the claims do not recite gelatin or pectin that cause bitterness when combined with acid, and the claims recite varieties of drugs from different drug categories, not only loratadine. As a matter of fact, current claims 9-11 recite acids in the method and composition, and it is not described what acids are excluded from the claims.
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).
Claims 3-4, and 6-13 are rejected as being dependent on rejected claim 2.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 6-13 are 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 claims are confusing because claim 2 recites “….liquid composition is substantially free of an acid catalyst for gelation…”, however claims 9-11 recite the composition further comprises acids. Are the acids of claim 2 different from those claimed by claims 9-11?
The term “substantially” in claim 2 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. How much acid catalyst that cause gelation is to be excluded from the claim to meet “substantially free”?
The boundaries of coverage is not imposed by the disclosure. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 9-11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 4, the claim broadens the scope of claim 2 from which the claim depends. Claim 4 recites gel carrier in a range of “from about 0.5 to about 3%” that is broader than the range of “1-3%” recited by claim 2.
Regarding claim 9-11, the claims broadens the scope of claim 2 from which claims 9-11 depend. Claims 9-11 recites “….the method of claim 2 further adding …acids….” that is broader than claim 2 that recites “substantially free from acid…..”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 2-4, 6, 8-10, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over combination of Buehler et al. (US 6,432,442, previously cited on PTO 892), or Romanoschi et al. (US 2016/0296474, IDS filed 09/13/2024), as evidenced by the article from Google, previously provided, and further in combination with any of the articles to Li et al. (“Carrageenan and its application in drug delivery” currently provided) or the article to Hotchkiss et al. (“The use of carrageenan in food”, currently provided).
Applicant Claims
Claim 2 is directed to a method for producing a chewable gel product, comprising:
a. formulating a liquid composition comprising 1-3 wt. % of a non-acid-activated gel carrier, 17.5-25 wt.% water, 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, diltiazcm, enalapril, captopril, ramipril, losartan, glyceroltrinitratc, alfuzosin, finastcridc, pravastatin, atorvastatin, simvastatin, gemfibrozil, metformin, terfenadine, celecoxib, rifecoxib, rivastignine, astemizole, hydroxyzine, clemastine, local anesthestics, antiseptics, opioids, sildenafil, tadalafil, vardenafil, and a pharmaceutically acceptable salt, ester, or hydrate thereof, wherein the liquid composition is substantially free of an acid catalyst for gelation; and
b. gelating the liquid composition at a temperature sufficient to yield a chewable gel product.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Buehler teaches soft chewable pharmaceutical dosage form for administering active agents from a chewable matrix. The matrix comprises hydrocolloid. Hydrocolloids improve taste and mouthfeel of the pharmaceutical matrix. The chewable matrix is pleasant, and easy to chew and swallow particularly to the children (abstract; col.2, lines 17-37; col.4, lies 34-50). The hydrocolloids include carrageenan (col.3, lines 1-15). Carrageenan is non-acid activated as evidenced by the article from Google. The active agents include antihistamine, dextromethorphan, pseudoephedrine in amount of 2-30% (col.3, lines 34-50; col.4, lines 15-20). The chewable dosage form further comprises 10-30% water for processing and stability, preferably 20-25% (col.4, lines 23-26; col.5, lines 17-23; claims). The dosage form comprises citric acid (example 1). The reference teaches method of making the chewable dosage form include the steps of mixing the ingredients, heating and cooling to the consistency that the mixture can be extruded and molded and cut to the desired dosage form, i.e. gelating the mixture (col.5, lines 29-55; col.6, lines 30-35).
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Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Buehler teaches carrageenan in chewable hydrocolloid drug matrix, the reference does not exemplifies carrageenan in particular.
Romanoschi teaches chewable dosage form comprising a gummy composition. for delivering active agents in improved palatable form to be chewed prior to swallowing to individuals have difficulty to swallow (abstract; ¶¶ 0009, 0090). The gummy composition comprises hydrophilic long chain polymers, pH modifier, and water (¶ 0021, 0077). The hydrophilic long chain polymers include carrageenan in amount of 1-20%, 1-15%, 2-7% (¶¶ 0078, 0084). Example 12, table 9, of the reference uses carrageenan. Carrageenan is non-acid activated as evidenced by the article from Google. The gummy composition comprises water in amount of 5-35%, 10-25%, or 16-22%, and table 9 teaches 20% (¶¶ 0021, 0085; table 9; claim 7). The pH modifier comprises citric acid, maleic acid, and phosphoric acid in amount up to 2%, e.g. 0.1-1% (¶¶ 0081, 0086). The chewable composition is suitable to deliver antihistamines (¶¶ 0019, 0070; and claim 6).
Li teaches carrageenan is used as gelling agent and viscosity enhancer for controlled drug release and prolonged retention (see the entire document, and in particular the abstract; and paragraphs 3.0 and 3.5).
Hotchkiss teaches carrageen is used in wide range of food industry and pharmaceuticals because of its multifunctional properties in providing gelling thickening and stabilization in water based formulations. It can replace gelatin (see the entire document and in particular the abstract and pages 234-236, 242).
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 a chewable gel dosage form comprising active agent, hydrocolloids including carrageen and water by the process taught by Buehler and use carrageenan exemplified by Romanoschi and taught by Li and Hotchkiss. One would have been motivated to do so because Buehler desired to include carrageen in the chewable formulation and because Romanoschi teaches gummy composition comprises carrageenan as preferred hydrocolloid as evidenced by exemplifying it, and because both Li and Hotchkiss teach suitability of using carrageenan in pharmaceuticals. One would reasonably expect formulating chewable composition comprising active agent, carrageenan and water wherein the composition is pleasant, and easy to chew and swallow, particularly to the children and individual having difficulty in swallowing.
Regarding the claimed amount of the gel carrier of 1-3% as claimed by claim 2, and 0.5-3% as claimed by claim 4, Buehler teaches 1-20%, 1-15%, 2-7%; and Romanoschi teaches 1-20%, 1-15%, 2-7%. The amounts taught by the references overlap with the claimed amounts. 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 claimed amount of water of 17.5-25% as claimed by claim 2, and 21% as claimed by claim 13, Buehler teaches from about 10-30% of water, and Romanoschi teaches 5-35%, 10-25%, or 16-22%, that overlaps with the claimed amounts. 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]. One having ordinary skill in the art would have determined the amount of water based on the used active agent and the desired consistency of the composition.
Regarding the gel carrier as claimed by claims 2-4, and 12, all the cited references teach carrageenan.
Regarding the active agents claimed by claims 2 and 6, Buehler teaches dextromethorphan, pseudoephedrine.
Regarding the claimed amount of active agent of 0.01-50% as claimed by claim 8, Buehler teaches 2-30% that overlap with 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 taste compatible acids as claimed by claims 9 and 10, Buehler, and Romanoschi teach the claimed citric acid.
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.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Buehler, Romanoschi and either Li or Hotchkiss as applied to claims 2-4, 6, 8-10,12-13 above, and further in view of Westhusing et al. (US 2011/0067180, IDS filed 09/13/2024).
Applicant Claims
Claim 7 recites the pharmaceutical ingredient of claim 2 is loratadine, and claim 11 recites the taste compatible agent of claim 9 is added in amount that yields a pH value ranging from about 3 to about 8.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Buehler, Romanoschi and either Li or Hotchkiss, are discussed above.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While both Buehler and Romanoschi both teach antihistaminic drug as active agent included in chewable dosage form, however the references do not teach loratadine claimed by claim 7.
While both Buehler and Romanoschi teach both teaches citric acid, however, the references do not explicitly teach the pH claimed by claim 11.
Westhusing teaches chewable dosage form that contains an active pharmaceutical ingredient, a gelling agent, water and a pH adjusting agent (abstract; ¶¶ 0007-0008, 0019, 0060, 0096, 0097, 0149-056). 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% 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 (¶ 00 84, 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).
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 a chewable gel composition comprising carrageenan, acid and active agent include antihistamines as taught by the combination of Buehler, Romanoschi and either Li or Hotchkiss, and use loratadine taught by Westhusing as antihistamine agent and further adjust the pH of the composition to 4-6, and preferably from 4.5-5.5 as taught by Westhusing . One would have been motivated to do so because Westhusing teaches suitability of loratadine and in composition having pH of 4-6 in a chewable composition without any unpleasant taste or problem with swallowing to improve patient compliance. One would reasonably expect producing pleasantly tasting chewable composition comprising carrageenan and loratadine and having pH between 4-6 that is easily swallowed therefore improving patient compliance.
Regarding the claimed pH of 3-8 as claimed by claim 11, Westhusing teaches pH 4-6, and preferably from 4.5-5.5 that falls within the claimed range of PH. 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].
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 2-4, 6-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 94, 95, 97, 100, 103 of copending Application No. 17/479,614. The subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent granted on the copending applications since the referenced copending applications and the instant application are claiming common subject matter as follows: a method for producing a chewable gel product, comprising: a. formulating a liquid composition comprising 1-3 wt. % of a gel carrier, 17.5-25% water, and an active pharmaceutical ingredient, wherein the gel carrier comprises carrageenan, and any combination thereof, and; b. gelating the liquid composition at a temperature sufficient to yield a chewable gel product. The copending claims anticipate the currently pending claims. Note the term comprising of the present claims allow combination of gelling agents and the presence of hydrogel comprising an aqueous phase.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive.
Rejections — 35 USC § 103
1. The Amended Claim is Patentable Over the Prior Art Combination.
Applicants argue that claim 2, as amended, recites that the liquid composition is "substantially free of an acid catalyst for gelation." This limitation is the crux of the invention and creates a functional incompatibility with the primary reference. Westhusing's system is unequivocally an acid-activated system. It is defined by its reliance on an acid catalyst (e.g., citric acid) to achieve a low pH (4-6), which is explicitly taught as being required for proper gelation of its pectin carrier (Westhusing, " 0068, 0084, 0196). The acid is not merely an incidental excipient; it is a functional and necessary component of the gelling mechanism itself. The amended claim requires the absence of this critical functional component. A person of ordinary skill in the art (POSA) simply cannot follow the teachings of Westhusing to create a gel and simultaneously arrive at a composition that is "substantially free of an acid catalyst for gelation." The two are mutually exclusive. Therefore, the proposed combination is not obvious; it is inoperable as described.
In response to this argument, it is argued that Westhusing teaches in paragraph [0084] using acids, e.g. citric acid, to adjust pH of the composition to reach pH 4-6 (paragraph [0196]), and not as a catalyst for gelation as applicants assert. Note that present claims 9-11 recite acids including citric acid to reach pH of 3-8.
Paragraph [0084] of the reference teaches: “ The semi-solid dosage form may optionally include a pH adjusting agent. Any suitable pH adjusting agent may be used that is sufficient to adjust the pH during the manufacture of the dosage form to yield the desired pH. By way of example, the pH adjusting agent may be sodium citrate, citric acid, sodium ascorbate and ascorbic acid. Two or more pH adjusting agents may be used. The pH adjusting agent may be supplied in solid form (e.g., as a powder) or in aqueous solution. For example, citric acid may be supplied in a 50% solution. Preferably, the pH adjusting agent is sodium citrate or citric acid. More preferably, both sodium citrate and citric acid are included in the semi-solid dosage form as pH adjusting agents.”
Paragraph [196 of the reference teaches: “A pH adjusting agent, such as citric acid, may be added to the base to provide a suitable pH for the final blend that contains all of the components of the semi-solid dosage form. The pH of the final blend is generally from about 4 to about 6, preferably from about 4.5 to about 5.5.”
The examiner respectfully disagrees with applicants that acid taught by the reference is functional component in the gelling mechanism. As shown from the teachings of Westhusing, there is no teaching of using the acid as catalyst of gelation, only acid used as pH adjusting agent as applicants had done and currently claiming. Applicants did not disclose that citric acid catalyze the hydrocolloids. Regardless what citric acid is used for by the reference or the claims, its function is inseparable from it. The present claims require acid to provide specific pH that is taught by the cited references.
2. The Combination is Based on Impermissible Hindsight.
Applicants argue that the motivation to combine the references is absent without the benefit of Applicant's disclosure. The Examiner suggests a motivation "to achieve taste masking effect." However, a POSA would not have been motivated to re-engineer Westhusing's entire gelling chemistry for this purpose. The prior art is silent on the specific problem of acid-API interaction causing bitterness. This problem was first identified by the Applicant (Current Application, ¶ [0004]). Without knowledge of this specific problem, a POSA would have no reason to believe that eliminating the acid catalyst was a viable or even desirable path to taste improvement.
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, even if motivation is different from what applicants had done. It should be noted that the 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. Further, reasonable expectation to achieve the present invention was presented. 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.").
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, in construing the rejection, the examiner relied upon what was known in the art before the effective filing date of the present invention, and not relied on applicant’s own disclosure. Note that the present claims did not eliminate acids from the claimed method, evident by current claims 9-11.
Applicants argue that the Examiner's own evidence (Office Action, p. 8) states that "low pH (acidic) conditions cause [carrageenan] to degrade." A POSA, knowing this, would be taught away from combining the carrageenan of Buehler with the mandatory low-pH, acid-catalyzed system of Westhusing, as it would be expected to lead to a failed formulation with a degraded gelling agent. The proposed combination is therefore technically irrational.
In response to this argument, it is noted that the examiner did not say anywhere in the office action that acidic pH degrade carrageenan.
The cited references are in the same field of applicants’ endeavor and seek to solve the same problems as the instant application and claims, chewable composition, and one of skill in the art is free to select components available in the cited prior art, In re Winslow, 151 USPQ 48 (CCPA, 1966). Further, the examiner recognizes that references cannot be arbitrarily combined that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references, In re Nomiya, 184 USPQ 607 (CCPA 1975). However, there is no requirement that a motivation to make the modification be expressly articulated. Combination of the cited references teaches the instantly claimed nonacid activated gelling agents resulting into pleasant taste to avoid bitterness of active agent as applicants had done.
The cited references do not teach away from the present invention because the present claims recite acids, claims 9-11. "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).
Withdrawn Claims & Double Patenting
Applicant acknowledges the withdrawal of claim 14 and the provisional nonstatutory double patenting rejection. To expedite prosecution, Applicant elects the invention of claims 2-13 without traverse and will address the double patenting rejection with a terminal disclaimer if it becomes necessary.
The examiner acknowledges applicants withdrawal of claim 14 without traverse, and intention to file terminal disclaimer when it becomes necessary,
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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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