DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 06/27/2025 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claims Status
Applicant's election with traverse of the species: ibuprofen active pharmaceutical agent; maple syrup suspension agent; water as the diluent; additional ingredients: blueberry flavoring agent; xylitol sugar, and citrus extract preservative; viscosity of less than 1500 centipoise at 22 degrees in the reply filed on 11/17/2025 is acknowledged. Since it obvious in view of Hass (United States Patent 4684666-see below) to adjust viscosity to achieve optimal stability, the viscosity species is withdrawn.
The traversal is on the ground(s) that there would not be a serious search burden and that to establish serious search burden the Office must show either A) separate classification for the several inventions; B) separate status in the art when they are classifiable together or C) a different field of search. The office states the different field of search but does not identify actual different classifications applicable to each of the different species.
This is not found persuasive because as noted in the restriction requirement, each of the different species would require a different field of search. For example, a search using search queries for an oral liquid containing dexamethasone is different than a search requiring ibuprofen. Similarly, search queries for the type of wetting agent, syrup flavoring agent and sugar would require different search terms. For example, a search for blueberry flavor would require different queries than searching for a citrus flavor. Applicants do not agree with the different field of search, however in addition to providing different search queries, the different species encompass separate classifications. For example, ibuprofen is classified as A61K31/192. Acetaminophen active is classified under A61k31/167. For the flavoring agents, blueberries has the classification of A01H6/74 whereas raspberries has the classification of A01H6/7499 and strawberry has the classification of A01H6/7409. For the sweetening agents, xylitol has the classification of A23L/29/30 whereas sugar alcohols have the classification of A23L/29/37. Agave syrup can be classified in A23L 33/125 and maple syrup can be classified in A23L33/105. Citric acid is classified under A23V2250/032 whereas lactic acid is classified under A23V2250/042. Accordingly, different classifications can be established, thus a search burden does indeed exist.
The requirement is still deemed proper and is therefore made FINAL.
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/17/2025. Claim 22 recites further comprising glycerin as a preservative which is an unelected species.
Claims 1-4 are being examined to the extent of the species elections: the elected active is ibuprofen, the elected suspension agent is maple syrup, the elected preservative is the acidic preservative of citrus extract, the elected diluent is water, the elected sugar is xylitol and the composition further comprises blueberry flavoring.
Claim Rejections - 35 USC § 103
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.
Claim 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Haas (United States Patent 4684666-IDS filed 6/27/2025) in view of Yano et al. (JPH10167988A) and Briganti et al. (United States Patent Publication 20160324207).
Claim 1 recites a pharmaceutical suspension comprising ibuprofen, suspension agent, preservative, sugar, and water.
The elected suspension agent is maple syrup, water as a diluent, the elected active is ibuprofen, the elected preservative is: acidic including citrus extract which is being interpreted as inclusive of citric acid, the elected suspension agent is maple syrup; the elected sugar is xylitol and the composition further comprises blueberry flavoring as the elected species.
Haas teaches ibuprofen syrups comprising ibuprofen suspended in aqueous (i.e. containing water) liquid, see abstract. The syrup can comprise sucrose sugar, see column 2 at lines 15-16. The viscosity of the syrup can comprise about 100-3000 centipoise at 20 degrees Celsius, see column 4, lines 9-18. The viscosity is controlled for optical stability within the range of 100-3000 centipoise, see column 4 lines 9-18. The viscosity recited in Hass of 100-3000 centipoise at 20 degrees Celsius overlaps the instantly claimed range of less than 1500 centipoise, less than 1000 centipoise, less than 750 centipoise and less than 600 centipoise. 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). Acidic preservatives may be added to the composition including ascorbyl palmitate, see column 3, lines 62-66 to column 4, lines 1-10. Hass teaches that fruit flavors including cherry or citrus are favorable to mask the taste of ibuprofen due to their slight bitter component, see column 4, lines 29-31.
Hass does not expressly teach the elected species to maple syrup, that the fruit flavor of the syrup is blueberry, that the sugar included is xylitol, or that the acidic preservative is citrus extract (i.e. citric acid).
However, Yano et al. teach oral liquids comprising bitter active containing ingredients including ibuprofen, see abstract and pages 2 and 6. The bitterness can be masked with maple flavors, thus providing improved flavor and taste masking effect of bitter drugs including ibuprofen, see pages 2-3 and 6. Maple flavors include maple syrup, see pages 2, 5, and 7. Additional agents including the sweetener xylitol or sucrose can be added, see pages 3 and 6.
Neither Hass nor Yano et al. teach citric acid added as a preservative to the oral syrups or blueberry flavoring agent.
However, Briganti et al. teach syrup formulations which comprise maple syrup, see claim 1 and paragraph [0026]. Citric acid is used as a preferred natural preservative and enhances taste, see paragraph [0030]. Flavoring agents are added including cherry or blueberry, see paragraph [0032].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the syrup of Hass with maple syrup, to substitute the preservative of Hass for citric acid, and to provide the fruit flavor of Hass as a blueberry flavor.
One of ordinary skill in the art would have been motivated to incorporate maple syrup to the syrup of Hass because Yano et al. teach that maple syrup is advantageous for being combined with bitter drugs including ibuprofen to help improve the flavor of the formulation and to taste mask the bitterness of drugs including ibuprofen. There would have been a reasonable expectation of success because both Hass and Yano et al. teach oral syrup formulations containing ibuprofen.
One of ordinary skill in the art would have been motivated to substitute the preservative of Hass for citric acid because Briganti teaches citric acid is a useful preservative for syrup formulations as citric acid is helps to enhance taste. There would have been a reasonable expectation of success because Hass teaches that acidic preservatives may be present and both Hass and Briganti teach oral syrup formulations.
One of ordinary skill in the art would have been motivated to include blueberry as the flavoring agent because Briganti teaches suitable flavoring agents include blueberry for oral syrups. Thus, one of ordinary skill in the art would have included blueberry to obtain a blueberry flavor for the syrup. There would have been a reasonable expectation of success because both Hass and Briganti teach oral syrup formulations with Hass teaching that preferred flavoring agents include fruit flavors.
Accordingly, claims 1-4 are rendered obvious over the teachings of Hass, Yano et al. and Briganti et al.
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18636379 in view of Briganti (United States Patent Publication 20160324207) and Dumas et al. (FR2993458).
Both the instant claims and that of Application ‘379 claim oral formulations which comprise syrup, active pharmaceutical agent, water and have viscosity including less than 1000 centipoise. The active pharmaceutical agent is ibuprofen, see claim 11 of Application ‘379. The preservative is inclusive of citric acid in both Applications, see claim 25 of Application 379 and diluent can comprise water. Application ‘379 contains flavoring agent but does not specify the kind.
The difference between the instant claims and that of Application ‘379 is the addition of maple syrup and blueberry flavoring agent.
However, Briganti et al. teach oral syrup formulations wherein the syrup is maple or agave, see paragraph [0026]. The oral syrup can comprise blueberry flavoring agent, see paragraph [0032].
Dumas et al. teaches that liquid oral syrups can comprise agave with maple syrup for those seeking to take low glycemic index syrups. Active agents include ibuprofen.
It would have been obvious to provide maple syrup with the agave syrup of Application ‘379 to provide a syrup formulation having low glycemic index suitable for people seeking low sugar intake. It would have additionally been obvious to provide blueberry flavor because Briganti teaches syrup formulations can be flavored with blueberry and Application ‘379 claims the presence of any flavoring agent.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-37 of copending Application No. 18958999 in view of Briganti (United States Patent Publication 20160324207), Dumas et al. (FR2993458) and Kupper (United States Patent 5560913).
Both the instant claims and of Application ‘999 claim syrup formulations which comprise diluent and have viscosities of less than 1500 centipoise. The syrup formulations further contain water as diluent, a flavoring agent and xylitol in both Applications. Both Applications claim citric acid preservative and the presence of a flavoring agent.
The difference between the instant claims and that of Application ‘999 is that the inclusion of ibuprofen with the syrup as Application ‘999 claims dextromethorphan hydrobromide with guaifenesin, and the inclusion of the elected species of blueberry flavor, with the inclusion of maple syrup.
However, Briganti et al. teach oral syrup formulations wherein the syrup is maple or agave, see paragraph [0026]. The oral syrup can comprise blueberry flavoring agent, see paragraph [0032].
Dumas et al. teaches that liquid oral syrups can comprise agave in combination with maple syrup for those seeking to take low glycemic index syrups, see pages 1-2 and 5-6. Active agents include ibuprofen in combination with guaifenesin, see page 2.
Kupper teaches oral liquid formulations comprising a pharmaceutical active agent including ibuprofen, dextromethorphan HBR, and guaifenesin see claim 1 and 4. The formulation can comprise a blueberry flavor and sugar sweetener, see claims 10 and 12. The carrier can comprise a syrup, see column 4, lines 36-40. The disorders being treated include respiratory illnesses such as common cold, see claim 16 and column 1, lines 42-55.
It would have been obvious to provide the liquid formulation of Application ‘999 with ibuprofen in combination with guaifenesin and dextromethorphan hydrobromide because Kupper teaches a combination of such actives for formulating a composition that treats respiratory illnesses including the common cold.
It would have additionally been obvious to provide maple syrup with the agave syrup of Application ‘999 to provide a syrup formulation having low glycemic index suitable for people seeking low sugar intake.
It would have been obvious to provide blueberry flavor because Briganti teaches syrup formulations can be flavored with blueberry and Application ‘999 claims any flavoring agent can be present.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-15 and 27 of copending Application No. 18/886,197 in view of Dumas et al. (FR2993458) and Kupper (United States Patent 5560913) and Yano et al. (JPH10167988A) and Briganti et al. United States Patent Publication 20160324207).
Both the instant claims and that of Application ‘197 claim pharmaceutical formulations for oral administration which comprise a syrup, diluent if water, and having a viscosity of less than 1500 centipoise. Claim 26 of Application ‘197 recites ibuprofen suspended in the syrup.
The difference between the instant claims and that of Application ‘197 is that the syrup is the elected maple syrup, the inclusion of ibuprofen with the syrup of claim 1 and 27 of Application ‘197 containing chlorpheniramine maleate or diphenhydramine HCL , and the inclusion of the elected species of blueberry flavor, citric acid preservative and the presence of xylitol sugar.
Dumas et al. teaches that liquid oral syrups can comprise agave in combination with maple syrup for those seeking to take low glycemic index syrups, see pages 1-2 and 5-6. Active agents include ibuprofen in combination with guaifenesin, see page 2.
Kupper teaches oral liquid formulations comprising a pharmaceutical active agent including ibuprofen, chlorpheniramine maleate and diphenhydramine HCL, see claim 1 and 4. The formulation can comprise a blueberry flavor and sugar sweetener, see claims 10 and 12. The carrier can comprise a syrup, see column 4, lines 36-40. The disorders being treated include respiratory illnesses such as common cold, see claim 16 and column 1, lines 42-55.
Yano et al. teach oral liquids comprising bitter active containing ingredients including ibuprofen, see abstract. The bitterness can be masked with maple flavors thus providing improved flavor and taste masking effect of the bitter ibuprofen. Maple flavors include maple syrup. Additional agents including the sweetener xylitol or sucrose can be added.
Briganti et al. teach syrup formulations which comprise maple syrup, see claim 1 and paragraph [0026]. Citric acid is used as an alternative to ascorbic acid for a preservative and enhances taste, see paragraph [0030]. Flavoring agents are added including strawberry or blueberry, see paragraph [0032].
It would have been obvious to provide the liquid formulation of Application ‘197 with ibuprofen in combination with chlorpheniramine and diphenhydramine HCL because Kupper teaches a combination of such actives for formulating a composition which can take the form of oral syrups for treatment of respiratory illnesses.
It would have additionally been obvious to provide the agave syrup of Application ‘197 with the maple syrup instantly claimed to provide a syrup formulation having low glycemic index suitable for people seeking low sugar intake as suggested by Dumas.
It would have been obvious to provide blueberry flavor to the syrup of Application ‘197 because Kupper and Briganti et al. teach oral formulations including syrups which can be flavored with blueberry. It would have been obvious to provide citric acid preservative with the oral formulations of Application ‘197 because Briganti teaches citric acid is used as a preservative for oral syrup formulations which enhances taste.
It would have been obvious to provide xylitol as a sugar to help enhance the bitterness of drugs including ibuprofen since Yano teaches xylitol can be added as a sugar with maple syrup to help enhance taste.
This is a provisional nonstatutory double patenting rejection
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/608,901 in view of Dumas et al. (FR2993458), Yano et al. (JPH10167988A) , Kupper (United States Patent 5560913) and Briganti et al. United States Patent Publication 20160324207).
Both the instant claims and that of Application ‘901 claim pharmaceutical formulations for oral administration which comprise a syrup, diluent and having a viscosity of less than 1000 centipoise. Both the instant claims and that of Application ‘901 claim a acidic preservative, and flavoring agent. Both the instant claims and that of Application ‘901 claim citric acid as the acidic preservative. Both Applications contain diluent.
The difference between the instant claims and that of the Application ‘197 is that the syrup is the elected maple syrup, the inclusion of ibuprofen with the syrup of, the inclusion of the elected species of blueberry flavor, and presence of xylitol sugar and water.
Dumas et al. teach that liquid oral syrups can comprise agave in combination with maple syrup for those seeking to take low glycemic index syrups, see pages 1-2 and 5-6. Active agents include ibuprofen in combination with guaifenesin, see page 2. Water is added to dilute the formulation, see examples 1-3.
Yano et al. teach oral liquids comprising bitter active containing ingredients including ibuprofen, see abstract, see pages 1-3. The bitterness can be masked with maple flavors thus providing improved flavor and taste masking effect of the bitter ibuprofen. Maple flavors include maple syrup, see pages 1-2. Additional agents including the sweetener xylitol can be added, see pages 3 and 6.
Kupper teaches oral liquid formulations comprising a pharmaceutical active agent including ibuprofen, dextromethorphan HBR, and guaifenesin see claim 1 and 4. The formulation can comprise a blueberry flavor and sugar sweetener, see claims 10 and 12. The carrier can comprise a syrup, see column 4, lines 36-40. The disorders being treated include respiratory illnesses such as common cold, see claim 16 and column 1, lines 42-55.
Briganti et al. teach syrup formulations which comprise maple syrup, see claim 1 and paragraph [0026]. Citric acid is used as an alternative to ascorbic acid for a preservative and enhances taste, see paragraph [0030]. Flavoring agents are added including strawberry or blueberry, see paragraph [0032].
It would have been obvious to provide the liquid formulation of Application ‘901 with ibuprofen in combination with dextromethorphan HBR and guaifenesin because Kupper teaches their combination for treatment of respiratory illnesses such colds.
It would have additionally been obvious to provide the agave syrup of Application ‘901 with the maple syrup instantly claimed to provide a syrup formulation having low glycemic index suitable for people seeking low sugar intake as suggested by Dumas. It would have been obvious to provide water as a diluent as Dumas teaches that water can dilute ibuprofen containing syrups and the claims of Application ‘901 are inclusive of any diluent.
It would have been obvious to provide blueberry flavor to the formulation of Application ‘091 because Briganti teaches oral formulations including syrups which can be flavored with blueberry. It would have been obvious to provide xylitol as a sugar to help enhance the bitterness of drugs including ibuprofen since Yano teaches xylitol can be added as a sugar with syrups to help enhance taste.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619