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 .
Claim Status
Applicant's election with traverse of a) viscosity range below 1000 centipoise b) from 0.01-1g of dextromethorphan HBR per 100mL of syrup and agave syrup constitutes les than 98% water and the election to a viscosity range of 200-600 centipoise in the replies filed on 05/27/2025 and 08/08/2025 is acknowledged. The traversal is on the ground(s) that there would not be an undue search burden to examine the full scope. This is not found persuasive because the inventions require a different filed of search using different search queries. For example, a search for one viscosity of 1500 may not necessarily yield another lower viscosity of 200-600.
Claims 1-19 are under current examination to the extent of the restriction elections.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 06/27/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Specification Objection
The specification is objected to because there does not appear to be any text for paragraph numbered [0036]. Appropriate correction is required.
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 1-7 and 11 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 term “palatable” in claim 1 is a relative term which renders the claim indefinite. The term “palatable” 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. The metes and bounds to be “palatable” are unclear. It is unclear if being palatable is the result of the combination of agave syrup or if there is other actives that are added to adjust the taste. Furthermore, what is palatable to one person may not be palatable to another, therefore palatable is a relative term and renders the claim indefinite.
Claim 11 recites wherein the preservative includes citric acid. The term “includes” is synonymous to “comprising, however claim 8 from which claim 11 depends recites a pharmaceutical composition “consisting of”. Therefore, the scope of the claim is unclear as it is unclear if the ingredients must consist of or comprise further ingredients. It is suggested that Applicants can recite wherein the acidic preservative is citric acid.
Claim Rejections - 35 USC § 112
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.
Claim 14 is 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. Claim 14 recites that the flavor agent functions as a bittersweet component. However, the claim does not further limit because claim 8 already requires flavoring agent. From the instant specification, the flavor agent is added to already mask the bitter taste pharmaceuticals (paragraph 0025). Claim 14 is not further limiting because the flavor agent is already added in claim 8, and the claim merely describes the function of flavoring agents. 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
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(s) 1-6, 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins et al. (United States Patent 9801400) in view of Heyer et al. (United States Patent Publication 20090148580).
Claim interpretation: With regards to claim 15, for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. Here, the instant specification does not define what the basic and novel characteristic are for a composition that “consists essentially of”, so the claim is being interpreted as equivalent to “comprising”.
Cummins et al. teach pharmaceutical syrup compositions, see column 5, lines 24-32 and entire document. The viscosity can comprise about 50-5000cps, see column 4, lines 31-36. In one embodiment the viscosity can comprise 100-1000 centipoise, see claim 9. Water (diluent) can be added from up to 10% by weight or pre preferably from 5-8%% by weight, see column 6, lines 38-40. Cummins et al. teach compositions which can be formulated as syrups, see column 5, lines 24-32. The compositions can comprise 0.133% dextromethorphan HBR, and 1.333 guaifenesin together with sucrose and flavoring agent and sodium benzoate preservative, see columns 9-10 examples 17-25. The composition can comprise citric extract such as lemon or lime, see column 7, lines 1-4.
Cummins does not teach that the syrup comprises agave present from 65-98% o the formulation or les than 98% by weight.
However, Heyer et al. teach that natural agave can replace sugars in medicines and promote a reduction of calories and elimination of artificial sweeteners, see abstract. Natural and artificial sweeteners are added to most medicines in a range from 2-98% by weight, see paragraph [0023]. Natural agave is a healthier alternative to traditional sweeteners like sucrose, see paragraphs [0004]-[0025]. Agave is considered a syrup like product, see paragraph [0005].
It would have been prima facie obvious to substitute the sucrose of Cummins for agave.
One of ordinary skill in the art would have been motivated to do so because Heyer teaches that for medicines agave is healthier than traditional sugars like sucrose and offers a formulation with reduction in caloric content.
There would have been a reasonable expectation of success given Cummins teaches the presence of sucrose sugar.
Per the teachings of Heyer, sweeteners can be added to medicinal formulations from 2-98% by weight, see paragraph [0023].
Regards to the viscosity, Cummins teaches an overlapping range and from MPEP 2144.05 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 diluent (water) can be present from up to 10% or from 5-8% rendering obvious a weight range of 5%. Furthermore the amount of the dextromethorphan HBR and guaifenesin, 0.133% w/v is equivalent to 0.133g dextromethorphan in 100mL solution. This amount overlaps and therefore renders obvious the claimed range of 0.01-1g dextromethorphan HBR per 100mL. From the teachings of Heyer, the agave can be present at a weight range from 2-98% overlapping a claimed range of less than 98% weight or from 65-98% by weight.
Accordingly, the teachings of Cummins et al. in view of Heyer et al. render the instant claims 1-6 and 5-18 obvious.
Claim(s) 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins et al. (United States Patent 9801400) in view of Heyer et al. (United States Patent Publication 20090148580-see IDS filed 6/27/2025) as applied to all claims above, and further in view of Dickerson et al. (United States Patent Publication 2005/0266031).
The teachings of Cummins and Heyer are discussed above. The modified Cummins does not teach that the syrup further comprises glycerin.
However, excipients such as glycerin are known to be added to pharmaceutical formulations as a humectant, see paragraph [0042]. The composition can comprise antitussives such as dextromethorphan HBR and guaifenesin expectorant, see paragraphs [0026]-[0029].
It would have been prima facie obvious to add glycerin to the pharmaceutical composition of Cummins.
One of ordinary skill in the art would have been motivated to do so to impart the desired humectant properties.
There would have been a reasonable expectation of success because both Cummins and Dickerson et al. teach oral formulations which comprise dextromethorphan HBR and guaifenesin.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11931413 in view of Dickerson et al. (United States Patent Publication 2005/0266031).
Both the instant claims and that of Patent ‘413 recite a syrup formulation comprising agave syrup having a viscosity of less than 1000 centipoise, the presence of a flavoring, acidic preservative and wherein the syrup can comprise less than 98% of the formulation by weight, wherein the diluent is about 5% by weight. The dextromethorphan can comprise HBR and present from 0.01-1% by weight with guaifenesin from 0.1-2 grams. The agave an be present at less than 98% of the formulation. The composition in both the instant claims and that of Patent ‘413 contain citric extract.
The difference between the instant claims and that of ‘413 is that the instant claims further comprises glycerin.
With regards to glycerin, it would have been obvious to add glycerin to the pharmaceutical formulation of Patent ‘413 in order to impart the desired humectant properties as Dickerson teaches that excipients such as glycerin are known to be added to pharmaceutical formulations as a humectant, see paragraph [0042]. The composition can comprise antitussives such as dextromethorphan and guaifenesin expectorant, see paragraphs [0026]-[0029].
Claims 1-7 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11617795 in view of Cummins et al. (United States Patent 9801400) and Dickerson et al. (United States Patent Publication 2005/0266031).
Both the instant claims and that of ‘795 recite a syrup formulation comprising agave syrup having a viscosity of less than 1500 centipoise, the presence of a flavoring, acidic preservative and wherein the syrup can comprise less than 98% of the formulation by weight, wherein the diluent is about 5% by weight. The agave can be present at less than 98% of the formulation. The composition in both the instant claims and that of Patent ‘795 can further contain citric acid.
The difference between the instant claims and that of “795 is that the instant claims contain a combination of dextromethorphan and guaifenesin whereas ‘795 is acetaminophen.
However, Cummins teaches syrup formulations which comprise acetaminophen, dextromethorphan HBR and guaifenesin. The pharmaceutical composition treats colds and flu like symptoms.
Thus it would have been obvious to provide dextromethorphan HBR with guaifenesin in order to treat colds. The dextromethorphan can be added at 0.133% by weight and the guaifenesin at 1.33%.
With regards to glycerin, it would have been obvious to add glycerin to the pharmaceutical formulation of Patent ‘795 in order to impart the desired humectant properties as Dickerson teaches that excipients such as glycerin are known to be added to pharmaceutical formulations as a humectant, see paragraph [0042]. The composition can comprise antitussives such as dextromethorphan and guaifenesin expectorant, see paragraphs [0026]-[0029].
Claims 1-7 and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4,15-24 of copending Application No. 18/201,375 (reference application) in view of Cummins et al. (United States Patent 9801400) and Dickerson et al. (United States Patent Publication 2005/0266031).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant clams and that of Application ‘375 are directed to pharmaceutical syrup formulations for oral use comprising a pharmaceutical agent, preservative flavoring agent and diluent, wherein the viscosity is less than 1000 centipoise. In both Applications the diluent can comprise 5% by weight. Both Applications can comprise preservative and a flavoring agent.
The difference between the instant claims and that of Application ‘375 is that the instant claims further comprise glycerin and the pharmaceutical agent is dextromethorphan HBR and guaifenesin and the presence of citric acid.
Cummins et al. teach pharmaceutical syrup compositions, see column 5, lines 24-32 and entire document. The viscosity can comprise about 50-5000cps, see column 4, lines 31-36. In one embodiment the viscosity can comprise 100-1000 centipoise, see claim 9. Water (diluent) can be added from up to 10% by weight or pre preferably from 5-8%% by weight, see column 6, lines 38-40. Cummins et al. teach compositions which can be formulated as syrups, see column 5, lines 24-32. The compositions can comprise 0.133% dextromethorphan HBR, and 1.333 guaifenesin together with sucrose and flavoring agent and sodium benzoate preservative, see columns 9-10 examples 17-25. The composition can comprise citric extract such as lemon or lime, see column 7, lines 1-4.
Heyer et al. teach that natural agave can replace sugars in medicines and promote a reduction of calories and elimination of artificial sweeteners, sea abstract. Natural and artificial sweeteners are added to most medicines in a range from 2-98% by weight, see paragraph [0023]. Natural agave is a healthier alternative to traditional sweeteners like sucrose, see paragraphs [0004]-[0025]. Agave is considered a syrup like product, see paragraph [0005].
It would have been prima facie obvious to provide agave to the syrup formulation of Application ’375 in an amount from 2-98% by weight and citric acid such as lemon or lime to impart flavor to the composition.
One of ordinary skill in the art would have been motivated to do so because Heyer teaches that for medicines agave is healthier than traditional sugars like sucrose and offers a formulation with reduction in caloric content.
It would have been obvious to provide dextromethorphan HBR with guaifenesin as the pharmaceutical agent of Application ‘375 in order to treat colds. The dextromethorphan can be added at 0.133% by weight and the guaifenesin at 1.33%.
With regards to glycerin, it would have been obvious to add glycerin to the pharmaceutical formulation of Application ‘375 in order to impart the desired humectant properties as Dickerson teaches that excipients such as glycerin are known to be added to pharmaceutical formulations as a humectant, see paragraph [0042]. The composition can comprise antitussives such as dextromethorphan and guaifenesin expectorant, see paragraphs [0026]-[0029].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/636,379 (reference application) in view of Cummins et al. (United States Patent 9801400) and Dickerson et al. (United States Patent Publication 2005/0266031).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant clams and that of Application ‘379 are directed to pharmaceutical syrup formulations for oral use comprising a pharmaceutical agent, preservative flavoring agent and diluent, wherein the viscosity is less than 1000 centipoise. In both Applications the diluent can comprise 5% by weight. Both Applications can comprise preservative and a flavoring agent. The agave can comprise less than 98
The difference between the instant claims and that of Application ‘379 is that the instant claims further comprise glycerin and the pharmaceutical agent is dextromethorphan HBR and guaifenesin and that the instant claims can comprise citric extract.
However, Cummins teaches syrup formulations which comprise dextromethorphan HBR and guaifenesin. The pharmaceutical composition treats colds and flu like symptoms. Cummins et al. teach pharmaceutical syrup compositions, see column 5, lines 24-32 and entire document. The viscosity can comprise about 50-5000cps, see column 4, lines 31-36. In one embodiment the viscosity can comprise 100-1000 centipoise, see claim 9. Water (diluent) can be added from up to 10% by weight or pre preferably from 5-8%% by weight, see column 6, lines 38-40. Cummins et al. teach compositions which can be formulated as syrups, see column 5, lines 24-32. The compositions can comprise 0.133% dextromethorphan HBR, and 1.333 guaifenesin together with sucrose and flavoring agent and sodium benzoate preservative, see columns 9-10 examples 17-25. The composition can comprise citric extract such as lemon or lime, see column 7, lines 1-4.
Thus it would have been obvious to provide dextromethorphan HBR with guaifenesin as the pharmaceutical agent of Application ‘379 in order to treat colds and citric extract such as lemon to help flavor the composition. The dextromethorphan can be added at 0.133% by weight and the guaifenesin at 1.33%.
With regards to glycerin, it would have been obvious to add glycerin to the pharmaceutical formulation of Application ‘379 in order to impart the desired humectant properties as Dickerson teaches that excipients such as glycerin are known to be added to pharmaceutical formulations as a humectant, see paragraph [0042]. The composition can comprise antitussives such as dextromethorphan and guaifenesin expectorant, see paragraphs [0026]-[0029].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-26, and 31-37 of copending Application No. 18,958999 reference application) in view of Cummins et al. (United States Patent 9801400) and Heyer et al. (United States Patent Publication 20090148580).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant clams and that of Application ‘999 are directed to pharmaceutical syrup formulations for oral use comprising dextromethorphan hydrobromide, guaifenesin, agave, and diluent, preservative flavoring agent and diluent can be added and the composition can comprise a viscosity inclusive of less than 1000 centipoise. Both Applications can comprise preservative.
The difference between the instant claims and that of Application ‘999 is the amount of agave present and the presence of citric extract.
However, Cummins teaches syrup formulations which comprise dextromethorphan HBR and guaifenesin. The pharmaceutical composition treats colds and flu like symptoms. Cummins et al. teach pharmaceutical syrup compositions, see column 5, lines 24-32 and entire document. The viscosity can comprise about 50-5000cps, see column 4, lines 31-36. In one embodiment the viscosity can comprise 100-1000 centipoise, see claim 9. Water (diluent) can be added from up to 10% by weight or pre preferably from 5-8%% by weight, see column 6, lines 38-40. Cummins et al. teach compositions which can be formulated as syrups, see column 5, lines 24-32. The compositions can comprise 0.133% dextromethorphan HBR, and 1.333 guaifenesin together with sucrose and flavoring agent and sodium benzoate preservative, see columns 9-10 examples 17-25. The composition can comprise citric extract such as lemon or lime, see column 7, lines 1-4.
Heyer et al. teach that natural agave can replace sugars in medicines and promote a reduction of calories and elimination of artificial sweeteners, sea abstract. Natural and artificial sweeteners are added to most medicines in a range from 2-98% by weight, see paragraph [0023]. Natural agave is a healthier alternative to traditional sweeteners like sucrose, see paragraphs [0004]-[0025].
It would have been prima facie obvious to provide agave in amounts from 2-98% by weight as a suitable sweetener.
One of ordinary skill in the art would have been motivated to do so because Heyer teaches that for medicines agave is healthier than traditional sugars like sucrose and offers a formulation with reduction in caloric content.
It would have additionally been obvious to provide citric acid extract of lemon as a flavoring agent to help impart a desired flavor to the syrup formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Currently no claims are allowed and all claims are rejected.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619