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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Australia on Oct. 28, 2022. An interim copy of the priority document, AU2022259844 was received on July 3, 2026.
Claim Status
Claims 11-22 are currently pending and subject to examination.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claims 13-15 under 35 U.S.C. 112(b) is withdrawn. This rejection was overcome by Applicant’s amendment to the claims.
Claim Rejections – 35 USC § 112(b) – Previously Presented
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.”
The rejection of claims 12, 16-20 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 is maintained.
Response to Arguments
Applicant argues that they have resolved the Markush grouping ambiguities for claims 12, 16-20 (Remarks, July 3, 2026, p. 7). Claim 12 is still indefinite because it is grammatically incomplete as it omits the verb “is.” One of ordinary skill in the art cannot determine the metes and bounds of claims 16-18 because they recite lists that are separated by the conjunction “and” indicating that each one of these is required in the claim and that they are not alternatives, but also use language “one or more” indicating that only one member of the list is required and that they are alternatives. Claims 19-20 improperly use a closed Markush grouping with the open conjunction “or.”
Applicant states that the functional phrase “for administering” was converted into an active method step (id.), however, this is not the case. Claims 16-18 still recite that “the medication is for administering or taking” and claims 19-20 still recite that the active ingredients “are each for administering or taking.” It therefore remains unclear whether these claims require the recited amounts, timing, and dosage forms be actually administered, or merely describe a medication capable of being administered in this way.
The amendment to claim 20 reciting “different dosing times” does not resolve the ambiguity noted in the prior office action because it is still unclear ow far apart two administrations must be to occur at a “single dosing time” or “different dosing time.” Furthermore, claim 20 appears to contradict the limitations of claim 11 because claim 11 requires administering a “medication comprising” paracetamol, ibuprofen and a non-sedative antihistamine, which reasonably conveys a singly medication containing all these ingredients.
Applicant states that they removed “such that” ambiguity (id.), however, the “such that” ambiguity is still present in the claims. Amended claim 19 recites “concurrently at a single dosing time, such that the active ingredients are administered wherein each active ingredient is administering in one or more dosage forms…” The added “wherein” clause makes the sentence grammatically incomplete because the relationship between the timing limitation and the dosage-form limitation is unclear.
Reiterated Rejection
Claims 12 and 16-20 have an improper listing of alternatives. One of ordinary skill in the art cannot determine the metes and bounds of claims 16-18 because they recite lists that are separated by the conjunction “and” indicating that each one of these is required in the claim and that they are not alternatives, but also use language “one or more” indicating that only one member of the list is required and that they are alternatives. Claims 19-20 improperly use a closed Markush grouping with the open conjunction “or.” Claim 12 is still indefinite because it is grammatically incomplete as it omits the verb “is.” Appropriate correction is required.
Claims 16-20 are also indefinite because it is unclear whether the drugs are actually administered, or in the required amounts. The claims recite that the active ingredients are “for administering or taking” – not “are administered” or “are taken”. The phrase “for administering” is intended use or functional language and does not describe any actual method steps. As such, a person of ordinary skill in the art would not know whether the claim limits the medication to a specific formulation or actually requires administering or taking the medication as in the claim.
In claim 20 it is also unclear what is meant by the “different dosing time” because neither the claims nor the specification describe the “dosing time” or indicates how far apart two administrations must be to occur at a “single dosing time” or “different dosing time.” If a patient takes an ibuprofen tablet, and then 10 minutes later takes an acetaminophen tablet and a cetirizine tablet, is that one dosage event or two? The claims and the specification provide no guidance. Additionally claim 20 is unclear in view of claim 11 from which it depends because claim 11 requires administering a “medication comprising” paracetamol, ibuprofen and a non-sedative antihistamine, which reasonably conveys a singly medication containing all these ingredients.
Claims 19 and 20 are further indefinite because it is unclear if the parenthetical “(or a pharmaceutically acceptable salt, or enantiomer of any mentioned aforesaid)” is a limitation which is part of the claimed invention.
Furthermore, the connector “such that” is a consequential or resultative phrase. It implies that the dosage forms are a consequence of the administration pattern, but that is logically incoherent. Whether one takes drugs at the same time or different times does not determine whether they come as tablet, capsules, aerosols or liquids. The dosage form is independent of the time. One of ordinary skill in the art would not know whether the “such that” clause is a separate limitation or if it is truly a consequence of the administration pattern.
Appropriate correction is required.
Claim Rejections – 35 USC § 102 – Previously Presented
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
“A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
The rejection of claim(s) 11-14, 16, and 18-19 under 35 U.S.C. 102(a)(1) as being anticipated by Uchida et al. (JP2008143807A) is maintained.
Response to Arguments
(a) Applicant argues that the “singly or as a mixture” passage refers to a mixture with other active ingredients, not to a mixture of ibuprofen and acetaminophen (Remarks, July 3, 2026, p. 8-10). These arguments were fully considered but are not persuasive. This reading is not supported by the and cannot be reconciled with Uchida as a whole. The passage states that “ibuprofen and acetaminophen are conventionally known as antipyretic analgesics used in cold medicine capsules” and that “these may be used singly or as a mixture.” Every composition Uchida discloses requires an antipyretic analgesic, an antiallergic agent, and a second drug (Uchida, Spec. Translation, p. 2, inventions 1-3). “Singly” cannot have the meaning the Applicant assigns to it because Uchida never contemplates an analgesic used as the sole active ingredient. Nor would Uchida need to state superfluously that the analgesic may be mixed with other active ingredients, because that is required in every embodiment. The only reading that gives the sentence meaning is that “singly” refers to one of the two named analgesics and “as a mixture” refers to both together.
Uchida’s usage of the same phrase elsewhere confirms this. Uchida states that the salts of antiallergic agents “may be used singly or as a mixture” and that the second drugs “may be used singly or as a mixture.” For example:
The second drug compounded in the cold medicine composition used in the present invention is an antitussive, an expectorant, a sputum solubilizer, a sympathomimetic drug, a parasympathomimetic blocker, or a central nervous system stimulant. These may be used singly or as a mixture.
Uchida, Translation, Spec., p. 3.
The antiallergic agents and second drugs cannot be the sole active ingredient in the invention, so in each case the phrase can only refer to one member or more than one member of the group just named. A skilled artisan reading the identical phrase applied to ibuprofen and acetaminophen would understand it the same way.
Uchida’s description of the manufacturing processing confirms this reading. Uchida describes adding ibuprofen and acetaminophen, together with a fat-soluble antiallergic agent, into a heated solvent and dissolving them:
Specifically, the cold medicine composition of the present invention can be produced as follows. If the antiallergic agent is fat-soluble, add ibuprofen and acetaminophen, a fat-soluble antiallergic agent (ebastine and loratadine), and a fat-soluble second agent into a heated solvent, mix and dissolve. After cooling the obtained solution, a solution in which cyclodextrin and a water-soluble second drug are dissolved is added to purified water and mixed.
Id., p. 4.
Uchida likewise describes dissolving ibuprofen and acetaminophen and a fat-soluble second drug warmed in solvent when the antiallergic agent is water soluble:
On the other hand, when the antiallergic agent is water-soluble, ibuprofen and acetaminophen and a fat-soluble second drug are dissolved in a warmed solvent, and the resulting solution is cooled and then added to purified water with cyclodextrin. Then, a water-soluble antiallergic agent (salts such as cetirizine hydrochloride and fexofenadine hydrochloride) and a water-soluble second drug are added and mixed.
Id.
In each passage, the original Japanese clearly joins ibuprofen and acetaminophen with 及び (oyobi), the conjunctive “and” (Uchida, Spec., p. 7, ll. 5, 9 (“イブプロフェン及びアセトアミノフェン” (emphasis added)). Uchida therefore describes a process in which both analgesics are dissolved in the same composition. This is a description of the very composition Applicant argues that Uchida does not disclose.
(b) Applicant argues that the anticipation argument requires impermissible picking and choosing (citing In re Arkley, In re Barid, Atofina) (Remarks, July 3, 2026, p. 9-10). These arguments were fully considered but are not persuasive. Arkley and Baird concern references that require selecting from multiple independent lists without direction to the claimed combination. This is not the case here. Every composition Uchida discloses contains one of four antiallergic agents: cetirizine, ebastine, fexofenadine, or loratadine. Each is a non-sedating antihistamine. The antihistamine limitation is therefore met by every embodiment, not selected from among alternatives. The only remaining choice is binary and Uchida expressly states that the analgesics may be used singly or as a mixture. Atofina is also distinguishable. It concerned a broad numerical range said to disclose a narrower range while the present rejection relies on an express statement about two named compounds. Again, as shown in (a), Uchida also describes added ibuprofen and acetaminophen to the same composition in the production process (Uchida, Translation, Spec., p. 4).
(c) Applicant argues that none of Uchida’s working examples contains both analgesics (Remarks, July 3, 2026, p. 9). These arguments were fully considered but are not persuasive. Anticipation does not require that the claimed embodiment appear in a working example, and the entire disclosure must be considered:
“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
MPEP § 2123.
(d) Applicant argues that anticipation cannot be established through inherency (Remarks, July 3, 2026, p. 10). This argument misapprehends the rejection because the rejection does not rely on inherency for the acetaminophen + ibuprofen + acetaminophen combination. That combination is expressly disclosed, as explained above. The only point addressed under inherency was administration to a human. “While Uchida does not explicitly state that a human is administered or takes the medication, this is inherent in the disclosure of Uchida because Uchida discloses a cold medicine composition for the alleviation of cold symptoms and daily doses of each API in the medicine (Uchida, Specification, Translation, p. 5).” (prior OA, p. 5). Furthermore, Uchida discloses a cold medicine capsule with specified daily doses for each active ingredient, to be divided in 6 to 9 capsules, for treating cold symptoms including excessive nasal discharge (Uchida, Spec., Translation, pp. 1-2, 5). A skilled artisan reading Uchida would understand it to describe administering the capsule to a human to alleviate cold symptoms, including nasal discharge, and through the recited antitussives, cough.
(e) Applicant argues that Uchida does not enable the claimed combination (Remarks, July 3, 2026, p. 10). This argument was fully considered but is not persuasive. Prior art patents and publications are presumptively enabled, and the applicant bears the burden of rebutting that presumption with evidence (MPEP § 2121). Applicant’s argument that Uchida is non-enabling because it does not disclose the combination is circular and unsupported by evidence. Uchida provides detailed guidance on solvent systems, blending ranges for each component, a step-by-step manufacturing method, daily dosage ranges for each active ingredient, and numerous working examples. Uchida also expressly discloses a process for preparing a mixture of ibuprofen and acetaminophen with fat-soluble and water-soluble anti-allergic agents, as shown in part (a) above. Thus, a skilled artisan could prepare and administer a formulation comprising both analgesics without undue experimentation.
Reiterated Rejection
Claim(s) 11-14, 16, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uchida et al. (JP2008143807A).
Claim 11 is directed towards method of treating or relieving any one or more of mucosal congestion, coughing, sinus secretions, dizziness, and nausea in a human by administering or taking medication comprising paracetamol, ibuprofen, and a non-sedative antihistamine or a pharmaceutically acceptable salt, or enantiomer, of any aforementioned.
This claim reads on a method comprising administering or taking medication comprising paracetamol, ibuprofen, and a non-sedative antihistamine or a pharmaceutically acceptable salt, or enantiomer, of any aforementioned because the claim does not recite that the human is in need of treatment (MPEP 2111.02).
The goal of the invention of Uchida is to treat cold symptoms such as cough and nasal congestion by combining antipyretic analgesics, selected from ibuprofen and acetaminophen (paracetamol), with non-sedating second-generation anti-histamines, selected from cetirizine, ebastine, fexofenadine and loratadine:
TECH-PROBLEM
Therefore, the object of the present invention is to have an excellent therapeutic effect on the symptoms of excessive nasal discharge (nasal nose) among various cold symptoms such as viral cold, bacterial cold, influenza, tonsillitis and the like. It is an object of the present invention to provide a cold-soluble or cold-type cold medicine capsule and a method for producing the same.
TECH-SOLUTION
As a result of earnest research to solve such problems, the present inventor, as an antipyretic analgesic selected from ibuprofen or acetaminophen, an antiallergic agent selected from the group consisting of cetirizine, ebastine, fexofenadine and loratadine, When using the antiallergic agent in combination with a cold medicine capsule that is used in combination with a second drug selected from antitussives, expectorants, sputum solubilizers, sympathomimetic stimulants, parasympathomimetic blockers and central nervous stimulants. It has been found that the coexistence of dextrin can effectively solve the solubility problem of the antiallergic agent, and the present invention has been achieved.
Uchida, Specification, Translation, p. 1-2.
Uchida specifically teaches a cold medicine capsule composition comprising:
(1) antipyretic analgesic selected from ibuprofen or acetaminophen,
(2) an antiallergic agent selected from the group consisting of cetirizine, ebastine, fexofenadine and loratadine,
(3) a second drug selected from the group consisting of an antitussive, an expectorant, a sputum solubilizer, a sympathomimetic agent, a parasympathomimetic blocker and a central nervous exciter; and
(4) cyclodextrin.
Uchida, Specification, Translation, p. 2.
In the best mode of the invention, Uchida specifically teaches that the ibuprofen and acetaminophen may be present in a mixture:
Here, ibuprofen and acetaminophen are conventionally known as antipyretic analgesics used in cold medicine capsules. These may be used singly or as a mixture.
Uchida, Specfication, Translation, p. 3.
Expanding on this disclosure, Uchida describes processes for preparing compositions with both ibuprofen and acetaminophen along with second generation non-drowsy antihistamines (ebastine, loratadine, cetirizine, and/or fexofenadine) and a second drug:
Specifically, the cold medicine composition of the present invention can be produced as follows. If the antiallergic agent is fat-soluble, add ibuprofen and acetaminophen, a fat-soluble antiallergic agent (ebastine and loratadine), and a fat-soluble second agent into a heated solvent, mix and dissolve. After cooling the obtained solution, a solution in which cyclodextrin and a water-soluble second drug are dissolved is added to purified water and mixed.
On the other hand, when the antiallergic agent is water-soluble, ibuprofen and acetaminophen and a fat-soluble second drug are dissolved in a warmed solvent, and the resulting solution is cooled and then added to purified water with cyclodextrin. Then, a water-soluble antiallergic agent (salts such as cetirizine hydrochloride and fexofenadine hydrochloride) and a water-soluble second drug are added and mixed.
Id., p. 4.
While Uchida does not explicitly state that a human is administered or takes the medication, a skilled artisan reading Uchida would understand it to describe administering the capsule to a human to alleviate cold symptoms, including nasal discharge, and through the recited antitussives, cough.
Therefore, claim 11 is anticipated.
Claim 12 is directed towards the method according to claim 11, wherein the non- sedative antihistamine is selected from the group consisting of cetirizine, bilastine, loratadine, and fexofenadine or a pharmaceutically acceptable salt, or enantiomer, of any aforementioned.
Uchida teaches that the antihistamine comprises cetirizine, loratadine, fexofenadine, or a mixture thereof:
The antiallergic agent blended in the cold medicine composition used in the present invention is selected from the group consisting of cetirizine, ebastine, fexofenadine and loratadine. These antiallergic agents are conventionally known. These antiallergic agents can also be used as salts. These salts include hydrochlorides, inorganic salts such as nitrates, sulfates, phosphates, oxalates, maleates, fumarate, tosylate, besylate, hydrobromide, Organic acid salts are preferred. These may be used singly or as a mixture.
Uchida, Specfication, Translation, p. 3.
Therefore, claim 12 is anticipated.
Claim 13 is directed towards the method of claim 12, wherein the medication comprises any one or more of guaifenesin, dextromethorphan, phenylephrine and pseudoephedrine or a pharmaceutically acceptable salt, or enantiomer, of any aforementioned.
Uchida teaches that the medication further includes an “an antitussive, an expectorant, a sputum solubilizer, a sympathomimetic drug, a parasympathomimetic blocker, or a central nervous system stimulant” wherein the preferred antitussive includes dextromethorphan, preferred expectorant includes guaifenesin, and preferred sympathomimetic includes pseudoephedrine hydrochloride (Uchida, Specification, Translation, p. 3).
Therefore, claim 13 is anticipated.
Claim 14 is directed towards the method according to claim 13, wherein one or more of the ingredients paracetamol, ibuprofen, cetirizine, bilastine, loratadine, fexofenadine, guaifenesin, dextromethorphan, phenylephrine and pseudoephedrine are combined in a dosage unit. As shown in the rejection of claims 11-13 above, Uchida teaches that the active ingredients are combined in a single dosage unit that is a capsule.
Therefore, claim 14 is anticipated.
Claim 16 recites:
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Claim 18 recites:
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Uchida teaches that the daily dose of loratadine is 1-10 mg:
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Uchida, Specification, Translation, p. 5.
Therefore, claims 16 and 18 are anticipated.
Claim 19 recites:
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As shown in the rejection of claim 11-14, 16, and 18 above, Uchida teaches cold medicine capsules comprising paracetamol (acetaminophen), ibuprofen and antihistamine for administering or taking at the same dosage event.
Therefore, claim 19 is anticipated.
Claim Rejections – 35 USC § 103 – Previously Presented
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.
The rejection of claim(s) 11-14, 16-19 and 21-22 under 35 U.S.C. 103 as being unpatentable over Uchida et al. (JP2008143807A), as applied to claims 11-14, 16 and 18-19 above is maintained.
The rejection of claim(s) 11-22 under 35 U.S.C. 103 as being unpatentable over Uchida et al. (JP2008143807A), as applied to claims 11-14 and 16-19 above, and further in view of Schachtel (US 8,771,643 B2) and “Pain and Fever Relief” (Brown Health Services Patient Education Series, July 2022, p. 1-2) (herein “Brown”) is maintained.
Claims 21-22 are newly added but are rejected using the same teachings of record.
Response to Arguments
(a) Applicant argues that the obviousness rejection depends entirely on the anticipation rejection (Remarks, July 3, 2026, p. 11). These arguments were fully considered but are not persuasive. The obviousness rejection stands independently. Uchida still expressly discloses using ibuprofen and acetaminophen as a mixture. Moreover, Uchida teaches that ibuprofen and acetaminophen are each antipyretic analgesics used for the same purpose in cold medicines. It is prima facie obvious to combine two compositions each taught by the prior art to be useful for the same purpose, in order to form a third composition for that same purpose (MPEP § 2144.06).
(b) Applicant argues that Uchida teaches away because antiallergic agents crystallize in the presence of coexisting drugs (Remarks, July 3, 2026, p. 12-13). These arguments were fully considered but are not persuasive. A reference teaches away only when it criticizes, discredits, or otherwise discourages the claimed solution. See In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Uchida does not discourage the claimed combination. It identifies a formulation problem (crystallization of the antiallergic agent in a liquid filled capsule) and solves it with cyclodextrin. Identifying a problem and giving a solution to the problem is the opposite of teaching away.
(c) Applicant argues that Uchida teaches “decreasing the number of coexisting drugs.” This argument was fully considered but is not persuasive. The examiner has reviewed the cited passages and does not identify this teaching. Uchida describes the crystallization problem as background. It then solves that problem while retaining all components: analgesic, antiallergic agent, second drug, and cyclodextrin. Uchida no where instructs the skilled artisan to reduce the number of active ingredients.
(d) Applicant argues that Uchida discloses no benefit to combining acetaminophen and ibuprofen, so the combination would be redundant. This argument was fully considered but is not persuasive. As shown in the anticipation analysis, Uchida discloses each and every element and limitation of the claimed invention and no secondary references are being “combined” to get to a composition comprising acetaminophen, ibuprofen and nonsedating antihistamine, making a motivation-to-combine analysis moot. Furthermore, in arguendo, Applicant’s own argument supplies the motivation to combine, because Uchida teaches that ibuprofen and acetaminophen are used for the same purpose and it is prima facie obvious to combine two compositions each taught by the prior art to be useful for the same purpose, in order to form a third composition for that same purpose (MPEP § 2144.06). Finally, the benefits of combining ibuprofen and acetaminophen are well known in the art, as demonstrated by Brown (“Tylenol and ibuprofen… may give more relief together than can be provided by using either alone,” at 2).
(e) Applicant argues that Uchida’s experimental data show that one analgesic is always favored over the other, so a skilled artisan would choose the better one (Remarks, July 3, 2026, pp. 12-13). This argument was fully considered but is not persuasive for several reasons. First, none of Uchida’s examples tests the mixture of both analgesics. The data therefore say nothing about how the combination performs. Second, the data compare antihistamine stability in a liquid filled capsule. Stability in that context has no bearing on the claimed therapeutic method, which does not require a specific dosage form, or even a single dosage unit. Third, Applicant’s interpretation of the tables is attorney argument, unsupported by a declaration (see MPEP § 716.01). Finally, a prior art preference for one embodiment does not teach away from other embodiments:
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
MPEP § 2123.
(f) Applicant argues the obviousness standard in terms of a “notional skilled addressee, who is “unimaginative”, must find a “scintilla” of inventiveness and is judged on a “balance of probabilities” (Remarks, July 3, 3026, p. 12). These arguments were fully considered but are not persuasive.
The standard described by the Applicant is not the standard applicable under 35 U.S.C. 103. 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.
The person of ordinary skill in the art is a “person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 421 (2007). Once Office personnel have issued a rejection that establishes the Graham factual findings and concludes, in view of the relevant evidence of record at that time, that the claimed invention would have been obvious as of the relevant time, the burden then shifts to the applicant to (A) show that the Office erred in these findings or (B) provide other evidence to show that the claimed subject matter would have been nonobvious (MPEP § 2141). Applicant has not shown that the Office erred in these findings nor submitted no objective evidence of nonobviousness.
(g) Applicant argues that the rejection asks what a skilled artisan “could” do rather than what they “would” do (Remarks, July 3, 2026, p. 12). This argument was fully considered but is not persuasive. The rejection does not rely on mere possibility. Uchida expressly states that the analgesics may be used as a mixture and describes a protocol for preparing them as a mixture, as shown above. Brown expressly teaches that using both provides more relief than either alone. These teachings establish what the skilled artisan has done or would have done and why.
(h) Applicant argues that the rejection relies on an “ex post facto analysis” (Id.). 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). Each element of the rejection is drawn from Uchida, Brown and Schachtel, not from Applicant’s specification. Application does not identify any limitation or rationale in the rejection that comes from the instant disclosure.
Reiterated Rejection
Claim(s) 11-14, 16-19 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uchida et al. (JP2008143807A), as applied to claims 11-14, 16 and 18-19 above.
The rejection of claims 11-14, 16 and 18-19 as anticipated by Uchida is incorporated herein by reference. As such, claims 11-14, 16 and 18-19 were prima facie obvious at the time of filing.
Claim 17 recites:
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One of ordinary skill in the art would have a reasonable expectation of success to administer the above ingredients in the indicated amounts because these amounts are generally known in the art.
For example, Uchida teaches that the usual daily dose of ibuprofen is 200 to 600 mg, acetaminophen 300 to 1,500 mg, cetirizine 2.5 to 25 mg, loratadine 1 to 10 mg and fexofenadine 30 mg:
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Uchida, Specification, Translation, p. 5.
Uchida also discloses specific examples of compositions that have dosage amounts that fall inside or are close to the claimed ranges (Machine Translation of Tables from JP2008143807A).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").
MPEP § 2144.05.
Therefore, claim 17 was prima facie obvious at the time of filing.
Claims 21 and 22 recite:
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One of ordinary skill in the art would have a reasonable expectation of success to administer the above ingredients in the indicated amounts because these amounts are generally known in the art.
For example, Uchida teaches that the usual daily dose of ibuprofen is 200 to 600 mg and acetaminophen 300 to 1,500 mg:
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Uchida, Specification, Translation, p. 5.
Therefore, claims 21-22 were prima facie obvious at the time of filing.
Claim(s) 11-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uchida et al. (JP2008143807A), as applied to claims 11-14 and 16-19 above, and further in view of Schachtel (US 8,771,643 B2) and “Pain and Fever Relief” (Brown Health Services Patient Education Series, July 2022, p. 1-2) (herein “Brown”).
The rejection of claims 11-14, 16-19 and 21-22 above as obvious over Uchida is incorporated herein by reference.
Claim 15 is directed towards the method of claim 13, wherein one or more of the ingredients paracetamol, ibuprofen, cetirizine, bilastine, loratadine, fexofenadine, guaifenesin, dextromethorphan, phenylephrine and pseudoephedrine are in separate dosage units.
As shown in the rejection of claims 11-14 and 16-19 above, Uchida teaches that the active ingredients are combined in a single dosage units (capsules). While Uchida does not teach that they can be combined in separate dosage units, one of ordinary skill in the art would have a reasonable expectation of success to administer the claimed active ingredients in separate dosage units because it is commonly known in the art that these active ingredients can be administered in separate dosage units for the treatment of cold symptoms.
For example, Schachtel teaches the combination of analgesics and antihistamines for potentiation of analgesia and the alleviation of symptoms including nausea, cough, and congestion, wherein the analgesic and antihistamine can be administered simultaneously or sequentially:
The methods can be used in a variety of therapeutic areas exhibiting adverse symptoms including, but not limited to, gastrointestinal (e.g., for patients with heartburn, abdominal pain, nausea and vomiting); respiratory (e.g., for patients with asthma, chronic obstructive lung disease, cough, nasal congestion)…
Schachtel, Specification, col. 3, lines 59-64;
In one aspect, the composition is prepared by admixing the analgesic and the antihistamine with a pharmaceutically-acceptable carrier. Alternatively, the analgesic and antihistamine are formulated such that the analgesic and the antihistamine are in separate delivery devices. In this aspect, the analgesic and the antihistamine can be administered to the subject separately and independently (e.g., to achieve immediate-release or delayed-release responses by and to one or both component drugs). In one aspect, the antihistamine can be administered first followed by the administration of the analgesic. For example, when the antihistamine is nizatidine and the analgesic is ibuprofen, the nizatidine can be administered first followed by the administration of ibuprofen. Not wishing to be bound by theory, when the nizatidine is an immediate-release preparation (e.g., a powder), the dissolution and bioavailability of the nizatidine is increased when compared to the slower dissolution and bioavailability of ibuprofen in a compressed tablet.
Schachtel, Specification, col. 8, lines 37-54.
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For example, Brown teaches that it is commonly known to alternate between taking acetaminophen and ibuprofen for maximal fever and pain relief and that both are in the form of tablets:
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Brown, p. 1-2.
Therefore, claim 15 was prima facie obvious at the time of filing.
Claim 20 is directed towards the method of claim 11, wherein the paracetamol, the ibuprofen and the non-sedative antihistamine (or a pharmaceutically acceptable salt, or enantiomer of any mentioned aforesaid) are each for administering or taking at different dosing time wherein each active ingredient is administered in one or more of the following forms: a) tablets, b) capsule, c) aerosol and d) liquid.
As shown above, one of ordinary skill in the art would have a reasonable expectation of success to administer the paracetamol, ibuprofen and non-sedating antihistamine at different dosage events because it is commonly known in the art to administer these agents at different dosage events. For example, see the teachings of Schachtel and Brown.
Therefore, claim 20 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Conclusion
No claim is found to be allowable.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
