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 .
Status of the Claims
Claims 7-8 and 16-25 are cancelled. Claims 26-27 are new. Claims 1-6, 9-15 and 26-27 are pending and under examination.
Priority
This application is a continuation of 17/821,138 filed on 8/19/2022, which is a continuation of 17/817,637 filed on 8/4/2022, which is a continuation of 17/342,414 filed on 6/8/2021, which is a continuation-in-part of 16/827,529 filed on 3/23/2020, which is a continuation of 15/912,785 filed on 3/6/2018, which claims priority to US provisional application 62/580,648 filed on 11/2/2017.
As the drugs in the claims (ibuprofen, chlorpheniramine maleate or diphenhydramine HCl or viscosity values were not present in application 16/827,529 filed on 3/23/2020 or priority documents prior to it, and only appeared in the CIP filing of 17/342,414 on 6/8/2021, the examiner will consider the claims as described on 6/8/2021 for the purpose of searching the prior art.
Information Disclosure Statement
The information disclosure statements filed on 06/27/2025 have been considered by the examiner.
Claim Objection
Claims 1, 26 and 27 are objected to for the word “diluant” which is more accurately spelled as “diluent”. 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 1-6, 9-15 and 26-27 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.
Claims 1-4, and 26-27 are indefinite as they do not provide for how the temperature is defined (Celsius, Fahrenheit or Kelvin). Depending on which temperature scale is used the claim will have a different meaning. For the purpose of compact prosecution the examiner will consider the temperatures in Celsius.
Claims 5-6 and 9-15 are rejected as being dependent on an indefinite claim.
Claims 11 and 12 are indefinite as less than 98% or less than 95% can include 0, which would render the agave syrup as optional where claim 1 provides agave syrup as an agent in the formulation. For the purpose of compact prosecution, the examiner will read the limitations as having at least a non-zero amount of agave syrup. Applicant may say “wherein the agave syrup is present in an amount that is less than…..” to clarify that some amount must be present.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. These claims allow for ranges of less than 98% or less than 95% for agave syrup, which extend down to zero. Claim 1, on which these claims depend, necessitates agave syrup, and thus, these claims extend the limitation so that agave syrup may be optional, which does not further limit claim 1 with having agave syrup. 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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qutishat FR2993457A1 (with English Translation).
Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup. The amount of ibuprofen in Qutishat example 3 would be 4 wt% (4g/100ml). As Qutishat’s composition is a liquid with a substantial amount of agave syrup, it will be a “syrup formulation”. In regards to viscosity, the composition comprises a drug, agave syrup and water as diluant. The water and agave syrup are the most substantial portion of the formulation in Qutishat. As it anticipates this mixture, the example 3 formulation will have such a viscosity in the range of applicant’s claim (see MPEP 2112.01 II, “A chemical composition and its properties are inseparable”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 9-13, 15 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Qutishat FR2993457A1 (with Google English translation) and Turck US6682747B1.
If the formulation of the prior art teaches citric components or citrus extracts, it will read on having a citric extract.
Qutishat teaches “Most liquid oral forms consist of refined sugar syrup that is not suitable for diabetic patients, people seeking a low caloric intake or those seeking ingredients of biological origin (certified). Thus this invention is based on biological agave syrup (certified) as a carrier for liquid dosage forms, pharmaceutical active ingredients (soluble, non-soluble and sparingly soluble) alone or in combination, suspending agents and aroma natural” (abstract). Qutishat teaches drugs such as analgesics including ibuprofen and antihistamines including chlorpheniramine and diphenhydramine (see claims of Qutishat). Example 2 teaches a formulation with diphenhydramine HCl, agave syrup and water, although the diphenhydramine HCl is dissolved in this syrup. Qutishat teaches active ingredients or other included compounds from 0.01 to about 90% of the formulation (page 3 and found in English translation). Qutishat teaches examples where the drug is suspended in the formulation (examples 3 and 4). Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup. As Qutishat’s composition is a liquid with a substantial amount of syrup, it will be a “syrup formulation”. The composition in example 2 has 0.2 grams of diphenhydramine (active agent) in 100 ml of formulation making it 0.2 wt%.
Qutishat teaches a composition with much of the components and structure, but does not discuss viscosity of the formulations.
Turck teaches a pharmaceutical composition that is an orally administered suspension (abstract). Turck teaches example formulation A with viscosity of 40-150 mPa.s (cP) and formulation B with viscosity of 60-200 mPa.s (cP). Turck teaches the viscosity of its formulations is low (Brief Summary of the Invention). Turck provides that solutions and syrups have the advantage of being taken easily and safely (Background of the invention). Turck teaches “unwanted increased in viscosity, which will prevent reconstitution of the suspension” in the Brief Summary of the Invention, and thus, envisions benefits of lowering the viscosity.
One of ordinary skill in the art before the time of filing would have produced oral pharmaceutical syrups of Qutishat with low viscosities of Turck which also teaches pharmaceutical oral substances in order to easily and safely administer forms that exhibit good reconstitution of the suspension for use as viscosity of such formulation is adjustable in teachings of the prior art. As Qutishat and Turck provide for amounts and ranges that overlap with applicant’s claims for active pharmaceuticals and excipients/carriers, one of ordinary skill in the art would work within such ranges to provide for other pharmaceutical formulations that have a drug, agave syrup, water and ingredients like citric acid with the reasonable expectation of success in producing other oral delivery systems for a drug. Qutishat recognizes the ability to have suspension forms of drugs with Turck further teaching suspension forms. Therefore, there was a reasonable expectation of success in producing low viscosity suspension formulations of active agents of the prior art in a formulation including those having agave syrup and water and having a formulation that is easily administered, safe and able to be reconstituted since the viscosity is not undesirably high.
Claim 14 in addition to Claims 1-6, 9-13, 15 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Qutishat FR2993457A1 (with Google English translation), Turck US6682747B1 and Heyer US 20090148580.
Qutishat and Turck teaches the claims as discussed above. The description of Qutishat provides for use of natural sweeteners with low glycemic index such as organic agave syrup (English translation of Qutishat).
Qutishat and Turck do not teach about 95% by weight of agave syrup in the composition.
Heyer teaches agave extract as a natural sweetener to replace all or part of the high-calorie sugars and or artificial sweeteners added in foods and medicines (abstract and claims of Heyer and paragraph 46). Heyer teaches sweeteners can range from 2 to 98% of the total content of food products and medicines (paragraph 23). Heyer teaches the extract as a syrup (paragraphs 4 and 5).
One of ordinary skill in the art before the time of filing would have used agave syrups/extracts in amounts up to 98% in medicinal products as they are seen as low calorie sweeteners for such products while Qutishat allows for the combination of pharmaceutical actives with agave syrup, water and other excipients. Thus, there was a reasonable expectation of success in using up to 98% of agave syrup with pharmaceutical compounds and getting a medicinal product with sweetened taste for oral administration.
Claim 27 in addition to Claims 1-6, 9-13, 15 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Qutishat FR2993457A1 (with Google English translation), Turck US6682747B1 and Angeles WO2015137829A1.
Qutishat and Turck teach the claims as discussed above. Qutishat does provide chlorpheniramine as a pharmaceutical agent as noted above.
Qutishat and Turck do not teach chlorpheniramine maleate, particularly.
Angeles teaches a stable and palatable liquid with a maleate salt of an antihistamine that includes chlorpheniramine maleate (abstract and claims 1 and 2 of Angeles and example 2).
One of ordinary skill in the art before the time of filing would have seen chlorpheniramine maleate as an acceptable form of chlorpheniramine for a palatable liquid formulation by the teachings of Angeles and would have used it as an option of chlorpheniramine for the products motivated by Qutishat and Turck. Qutishat already provides a teaching to provide chlorpheniramine as one of its active agents. There would be a reasonable expectation of success in using the chlorpheniramine maleate in agave syrup and water containing formulations of the prior art and getting effective treatment in conditions needing anthistamines for treatment.
Non-Statutory 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 1-6, 9-15 and 26-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11617795 in view of Qutishat FR2993457A1 (with Google English translation) and Angeles WO2015137829A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for the same formulation ingredients, viscosities and concentrations as in applicant’s claims.
‘795 provides for a different drug.
Qutishat teaches “Most liquid oral forms consist of refined sugar syrup that is not suitable for diabetic patients, people seeking a low caloric intake or those seeking ingredients of biological origin (certified). Thus this invention is based on biological agave syrup (certified) as a carrier for liquid dosage forms, pharmaceutical active ingredients (soluble, non-soluble and sparingly soluble) alone or in combination, suspending agents and aroma natural” (abstract). Qutishat teaches drugs such as analgesics including ibuprofen and antihistamines including chlorpheniramine and diphenhydramine (see claims of Qutishat). Example 2 teaches a formulation with diphenhydramine HCl, agave syrup and water, although the diphenhydramine HCl is dissolved in this syrup. Qutishat teaches active ingredients or other included compounds from 0.01 to about 90% of the formulation (page 3 and found in English translation). Qutishat teaches examples where the drug is suspended in the formulation (examples 3 and 4). Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup.
Angeles teaches a stable and palatable liquid with a maleate salt of an antihistamine that includes chlorpheniramine maleate (abstract and claims 1 and 2 of Angeles and example 2).
One of ordinary skill in the art would have considered other drugs/active ingredients suitable for oral liquid formulations taught in the prior art as they serve as drug delivery systems. Note that Qutishat recognizes active ingredients as interchangeable in its teachings. There would be a reasonable expectation of success in the addition or substitution of other pharmaceutical ingredients to make new formulations having the same carrier/vehicle composition as in the prior art.
Claims 1-6, 9-15 and 26-27 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 Qutishat FR2993457A1 (with Google English translation) and Angeles WO2015137829A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for the same formulation ingredients, viscosities and concentrations as in applicant’s claims.
‘413 provides for a different drug.
Qutishat teaches “Most liquid oral forms consist of refined sugar syrup that is not suitable for diabetic patients, people seeking a low caloric intake or those seeking ingredients of biological origin (certified). Thus this invention is based on biological agave syrup (certified) as a carrier for liquid dosage forms, pharmaceutical active ingredients (soluble, non-soluble and sparingly soluble) alone or in combination, suspending agents and aroma natural” (abstract). Qutishat teaches drugs such as analgesics including ibuprofen and antihistamines including chlorpheniramine and diphenhydramine (see claims of Qutishat). Example 2 teaches a formulation with diphenhydramine HCl, agave syrup and water, although the diphenhydramine HCl is dissolved in this syrup. Qutishat teaches active ingredients or other included compounds from 0.01 to about 90% of the formulation (page 3 and found in English translation). Qutishat teaches examples where the drug is suspended in the formulation (examples 3 and 4). Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup.
Angeles teaches a stable and palatable liquid with a maleate salt of an antihistamine that includes chlorpheniramine maleate (abstract and claims 1 and 2 of Angeles and example 2).
One of ordinary skill in the art would have considered other drugs/active ingredients suitable for oral liquid formulations taught in the prior art as they serve as drug delivery systems. Note that Qutishat recognizes active ingredients as interchangeable in its teachings. There would be a reasonable expectation of success in the addition or substitution of other pharmaceutical ingredients to make new formulations having the same carrier/vehicle composition as in the prior art.
Claims 1-6, 9-15 and 26-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12629422. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for the same formulation ingredients, viscosities and concentrations as in applicant’s claims. ‘422 provides for ibuprofen, chlorphenarime maleate and diphenhydramine HCl in its dependent claims as active pharmaceutical ingredients.
Claims 1-6, 9-14, 26 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending application 18/201375 in view of Qutishat FR2993457A1 (with Google English translation), Heyer US 20090148580, and Angeles WO2015137829A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for similar form, formulation ingredients, and viscosities as in applicant’s claims.
‘375 provides for a different drug and does not define the suitable sugar as agave syrup.
Qutishat teaches “Most liquid oral forms consist of refined sugar syrup that is not suitable for diabetic patients, people seeking a low caloric intake or those seeking ingredients of biological origin (certified). Thus this invention is based on biological agave syrup (certified) as a carrier for liquid dosage forms, pharmaceutical active ingredients (soluble, non-soluble and sparingly soluble) alone or in combination, suspending agents and aroma natural” (abstract). Qutishat teaches drugs such as analgesics including ibuprofen and antihistamines including chlorpheniramine and diphenhydramine (see claims of Qutishat). Example 2 teaches a formulation with diphenhydramine HCl, agave syrup and water, although the diphenhydramine HCl is dissolved in this syrup. Qutishat teaches active ingredients or other included compounds from 0.01 to about 90% of the formulation (page 3 and found in English translation). Qutishat teaches examples where the drug is suspended in the formulation (examples 3 and 4). Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup. The description of Qutishat provides for use of natural sweeteners with low glycemic index such as organic agave syrup (English translation of Qutishat).
Heyer teaches agave extract as a natural sweetener to replace all or part of the high-calorie sugars and or artificial sweeteners added in foods and medicines (abstract and claims of Heyer and paragraph 46). Heyer teaches sweeteners can range from 2 to 98% of the total content of food products and medicines (paragraph 23). Heyer teaches the extract as a syrup (paragraphs 4 and 5).
Angeles teaches a stable and palatable liquid with a maleate salt of an antihistamine that includes chlorpheniramine maleate (abstract and claims 1 and 2 of Angeles and example 2).
One of ordinary skill in the art would have considered other drugs/active ingredients suitable for oral liquid formulations and agave syrup as a sweetener/sugar taught in the prior art as they serve as drug delivery systems. Note that Qutishat recognizes active ingredients as interchangeable in its teachings. One of ordinary skill in the art would also adjust the amounts of ingredients based on teachings of ranges, values and overlapping ranges of the prior art in providing such oral delivery liquids/syrups. There would be a reasonable expectation of success in the addition or substitution of other pharmaceutical ingredients to make new formulations having the same carrier/vehicle composition as in the prior art.
This is a provisional double patenting rejection as the claims have not yet been issued as a patent.
Claims 1-6, 9-15 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 9, 14, 20, 23-24, 31-33, and 36 of copending application 18/630363. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for the same formulation ingredients, viscosities and concentrations as in applicant’s claims. ‘363 provides for ibuprofen, chlorphenarime maleate and diphenhydramine HCl in its dependent claims as active pharmaceutical ingredients.
This is a provisional double patenting rejection as the claims have not yet been issued as a patent.
Claims 1-6, 9-14, 26 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-25, 35-37 of copending application 18/958,999 in view of Qutishat FR2993457A1 (with Google English translation), Heyer US 20090148580, and Angeles WO2015137829A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for similar form, formulation ingredients, and viscosities as in applicant’s claims.
‘999 provides for a different drug and lacks concentrations of the active agent and agave.
Qutishat teaches “Most liquid oral forms consist of refined sugar syrup that is not suitable for diabetic patients, people seeking a low caloric intake or those seeking ingredients of biological origin (certified). Thus this invention is based on biological agave syrup (certified) as a carrier for liquid dosage forms, pharmaceutical active ingredients (soluble, non-soluble and sparingly soluble) alone or in combination, suspending agents and aroma natural” (abstract). Qutishat teaches drugs such as analgesics including ibuprofen and antihistamines including chlorpheniramine and diphenhydramine (see claims of Qutishat). Example 2 teaches a formulation with diphenhydramine HCl, agave syrup and water, although the diphenhydramine HCl is dissolved in this syrup. Qutishat teaches active ingredients or other included compounds from 0.01 to about 90% of the formulation (page 3 and found in English translation). Qutishat teaches examples where the drug is suspended in the formulation (examples 3 and 4). Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup. The description of Qutishat provides for use of natural sweeteners with low glycemic index such as organic agave syrup (English translation of Qutishat).
Heyer teaches agave extract as a natural sweetener to replace all or part of the high-calorie sugars and or artificial sweeteners added in foods and medicines (abstract and claims of Heyer and paragraph 46). Heyer teaches sweeteners can range from 2 to 98% of the total content of food products and medicines (paragraph 23). Heyer teaches the extract as a syrup (paragraphs 4 and 5).
Angeles teaches a stable and palatable liquid with a maleate salt of an antihistamine that includes chlorpheniramine maleate (abstract and claims 1 and 2 of Angeles and example 2).
One of ordinary skill in the art would have considered other drugs/active ingredients suitable for oral liquid formulations and agave syrup as a sweetener/sugar taught in the prior art as they serve as drug delivery systems. Note that Qutishat recognizes active ingredients as interchangeable in its teachings. One of ordinary skill in the art would also adjust the amounts of ingredients based on teachings of ranges, values and overlapping ranges of the prior art in providing such oral delivery liquids/syrups. There would be a reasonable expectation of success in the addition or substitution of other pharmaceutical ingredients to make new formulations having the same carrier/vehicle composition as in the prior art.
This is a provisional double patenting rejection as the claims have not yet been issued as a patent.
Claims 1-6, 9-14, 26 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8, 11 of copending application 19/198,952 in view of Qutishat FR2993457A1 (with Google English translation), Heyer US 20090148580, and Angeles WO2015137829A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for similar form, formulation ingredients, and viscosities as in applicant’s claims.
‘952 provides for a different drug and lacks concentrations of the active agent and agave.
Qutishat teaches “Most liquid oral forms consist of refined sugar syrup that is not suitable for diabetic patients, people seeking a low caloric intake or those seeking ingredients of biological origin (certified). Thus this invention is based on biological agave syrup (certified) as a carrier for liquid dosage forms, pharmaceutical active ingredients (soluble, non-soluble and sparingly soluble) alone or in combination, suspending agents and aroma natural” (abstract). Qutishat teaches drugs such as analgesics including ibuprofen and antihistamines including chlorpheniramine and diphenhydramine (see claims of Qutishat). Example 2 teaches a formulation with diphenhydramine HCl, agave syrup and water, although the diphenhydramine HCl is dissolved in this syrup. Qutishat teaches active ingredients or other included compounds from 0.01 to about 90% of the formulation (page 3 and found in English translation). Qutishat teaches examples where the drug is suspended in the formulation (examples 3 and 4). Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup. The description of Qutishat provides for use of natural sweeteners with low glycemic index such as organic agave syrup (English translation of Qutishat).
Heyer teaches agave extract as a natural sweetener to replace all or part of the high-calorie sugars and or artificial sweeteners added in foods and medicines (abstract and claims of Heyer and paragraph 46). Heyer teaches sweeteners can range from 2 to 98% of the total content of food products and medicines (paragraph 23). Heyer teaches the extract as a syrup (paragraphs 4 and 5).
Angeles teaches a stable and palatable liquid with a maleate salt of an antihistamine that includes chlorpheniramine maleate (abstract and claims 1 and 2 of Angeles and example 2).
One of ordinary skill in the art would have considered other drugs/active ingredients suitable for oral liquid formulations and agave syrup as a sweetener/sugar taught in the prior art as they serve as drug delivery systems. Note that Qutishat recognizes active ingredients as interchangeable in its teachings. One of ordinary skill in the art would also adjust the amounts of ingredients based on teachings of ranges, values and overlapping ranges of the prior art in providing such oral delivery liquids/syrups. There would be a reasonable expectation of success in the addition or substitution of other pharmaceutical ingredients to make new formulations having the same carrier/vehicle composition as in the prior art.
This is a provisional double patenting rejection as the claims have not yet been issued as a patent.
Claims 1-6, 9-14, 26 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-11, 16-18 of copending application 19/198,978 in view of Qutishat FR2993457A1 (with Google English translation), Heyer US 20090148580, and Angeles WO2015137829A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for similar form, formulation ingredients, and viscosities as in applicant’s claims.
‘978 provides for a different drug and lacks concentrations of the active agent and agave.
Qutishat teaches “Most liquid oral forms consist of refined sugar syrup that is not suitable for diabetic patients, people seeking a low caloric intake or those seeking ingredients of biological origin (certified). Thus this invention is based on biological agave syrup (certified) as a carrier for liquid dosage forms, pharmaceutical active ingredients (soluble, non-soluble and sparingly soluble) alone or in combination, suspending agents and aroma natural” (abstract). Qutishat teaches drugs such as analgesics including ibuprofen and antihistamines including chlorpheniramine and diphenhydramine (see claims of Qutishat). Example 2 teaches a formulation with diphenhydramine HCl, agave syrup and water, although the diphenhydramine HCl is dissolved in this syrup. Qutishat teaches active ingredients or other included compounds from 0.01 to about 90% of the formulation (page 3 and found in English translation). Qutishat teaches examples where the drug is suspended in the formulation (examples 3 and 4). Qutishat teaches in “Example 3 Ingredients% w / v Ibuprofen 4.0 g Certified Agave Syrup 45 g Xanthan Gum 0.4 g Agar Agar Certified 0.2 g Glycerin 5 g Sodium Citrate 0.70 g Citric Acid Anhydrous 0.6 g Natural Flavoring Strawberry 0.01 g Purified Water Up 100ml. Xanthan gum and agar-agar are mixed with glycerin to give solution A. Ibuprofen is suspended in agave syrup to give solution B. Solutions A are added to B Then water is added and mixed, then the other ingredients are added and mixed and then placed in 5 ml or 100 ml flasks.” This composition would have 45% by weight of agave syrup, 0.6% by weight of citric acid, and example 3 provides for ibuprofen being suspended in agave syrup. The description of Qutishat provides for use of natural sweeteners with low glycemic index such as organic agave syrup (English translation of Qutishat).
Heyer teaches agave extract as a natural sweetener to replace all or part of the high-calorie sugars and or artificial sweeteners added in foods and medicines (abstract and claims of Heyer and paragraph 46). Heyer teaches sweeteners can range from 2 to 98% of the total content of food products and medicines (paragraph 23). Heyer teaches the extract as a syrup (paragraphs 4 and 5).
Angeles teaches a stable and palatable liquid with a maleate salt of an antihistamine that includes chlorpheniramine maleate (abstract and claims 1 and 2 of Angeles and example 2).
One of ordinary skill in the art would have considered other drugs/active ingredients suitable for oral liquid formulations and agave syrup as a sweetener/sugar taught in the prior art as they serve as drug delivery systems. Note that Qutishat recognizes active ingredients as interchangeable in its teachings. One of ordinary skill in the art would also adjust the amounts of ingredients based on teachings of ranges, values and overlapping ranges of the prior art in providing such oral delivery liquids/syrups. There would be a reasonable expectation of success in the addition or substitution of other pharmaceutical ingredients to make new formulations having the same carrier/vehicle composition as in the prior art.
This is a provisional double patenting rejection as the claims have not yet been issued as a patent.
Claims 1-6, 9-15, 26 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application 19/679,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims provide for similar form, formulation ingredients, concentration ranges and viscosities as in applicant’s claims. ‘231 claims provide for the active ingredients in applicant’s claims in a group of active ingredients.
This is a provisional double patenting rejection as the claims have not yet been issued as a patent.
Conclusions
No claim is allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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