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 .
Status of the Claims
Claims 2-15 are pending.
Priority
This application filed on09/09/2024, is a CON of Y.S. application No. 17/867,370, filed on 07/18/2022 (U.S. patent No. 12,083,087), which is a CON of U.S. application No. 17/502,899, filed on 10/15/2021 (U.S. patent No. 11,389,416), which is a CON of U.S. application No. 16/424,274, filed on 05/28/2019 (U.S. patent No. 11,213,498), which is a DIV of U.S. application No. 15/326,958, filed 01/17/2017 (U.S. patent No. 11,219,609), which is a 371 of PCT/EPO2015/066466, filed on 07/17/2015, which claims priority to PCT/EP2014/065544, filed on 07/18/2014. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/24/2025, was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-15 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 3-14 depend from claim 2 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
The recited limitation of “aqueous solution comprising water” in claims 2-6, 10 and 15, is superfluous in that a person skilled in the art would have readily understood that an aqueous solution comprises water (see, e.g., ¶ 0032 of the specification). It is recommended that the phrase “comprising water”, be deleted in order to overcome the rejection. Appropriate correction is required.
Claim 14 recites the limitation “the level of 4-aminophenol” and “the level of 4-nitrophenol”, in lines 1-3. There is insufficient antecedent basis for these limitations in the claim. Claim 14 lacks antecedent basis because claim 2 from which claim 14 depends fails to recite the limitation “a level of 4-aminophenol” and “a level of 4-nitrophenol”. Appropriate correction is required.
Claim 15 recites the phrase “wherein the ibuprofen and the paracetamol remain in solution in the pharmaceutical composition after preparation for at least 6 months at 25 oC ± 2 oC and 40% ± 5% relative humidity” (lines 10-12), however, it is unclear as to how the recites phrase further limits claim 15, since the phrase “wherein the ibuprofen and the paracetamol remain in solution in the pharmaceutical composition after preparation for at least 6 months at 25 oC ± 2 oC and 40% ± 5% relative humidity”, is recited in the claim preamble (lines 2-4). Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
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.
Claims 2-8, 10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson (U.S. Pub. No. 20130225685, published 08/29/2013) in view of: 1) Tseti (U.S. Pub. No. 20130210922, published 08/15/2013); and 2) Pavliv et al (hereinafter “Pavliv”, U.S. Pub. No. 20130245591, published 09/19/2013).
Independent claims 2 and 15 are directed to a process for making an aqueous composition and having a pH of 6.3 to 6.8 and comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10-2 mg/ml paracetamol.
Regarding claims 2 and 15, Atkinson discloses an aqueous composition comprising 3.0 mg/ml ibuprofen and 10.0 mg/ml paracetamol (see ¶s 0031-0032 and Example 2). Atkinson discloses that the inventive composition can be delivered to a human in order to treat pain and/or inflammation, wherein the composition can comprise: i) from approximately 125 mg to approximately 325 mg ibuprofen; and ii) from approximately 475 mg to approximately 1,025 mg paracetamol. Please see ¶s 0007-0009.
Atkinson discloses that the inventive aqueous solution can be formulated using suitable excipients as will be known to those with ordinary skill in the art of formulating intravenous medicines. The excipients may include suitable antioxidants, pH modulators sufficient to give a pH of 5 to 6, buffering agents, isotonic agents and purified water. Please see ¶s 0031, 0040-0043 and Examples 3-4. The ibuprofen and paracetamol are mixed with suitable excipients to give the desired volumes. Please see ¶s 0030-0033, 0040-0043 and Examples 3-4.
Atkinson discloses that an aqueous combination composition at lower ibuprofen dose, was found to surprisingly and unexpectedly provide adequate pain relief every 6 hours for some patients that would otherwise need to take higher ibuprofen dose every 8 hours. The lower ibuprofen dose reduces the risk of undesirable side effects associate with high ibuprofen dosage, without compromising the effectiveness of ibuprofen due to the presence of paracetamol. Please see ¶ 0037.
Accordingly, at the time the instant invention was filed, an artisan of the ordinary skill would have considered formulating an aqueous combination composition comprising ibuprofen and paracetamol as disclosed and suggested by Atkinson for the advantage of: i) providing adequate pain relief every 6 hours for some patients that would otherwise need to take higher ibuprofen dose every 8 hours; and ii) reducing the risk of undesirable side effects associate with high ibuprofen dosage, without compromising the effectiveness of ibuprofen.
Atkins differs from claims 2 and 15 only insofar as Atkins does not explicitly disclose a composition at a pH of 6.3-6.8.
However, Atkinson discloses that while some preferred forms of the invention have been described by way of example it should be appreciated that modifications and improvements can occur without departing from the scope of the invention (see ¶ 0044).
Accordingly, at the time the instant invention was filed, a person of the ordinary skill in the art would have understood that Atkinson contemplates formulation of an aqueous combination composition comprising ibuprofen and paracetamol within the scope of the invention, and with modification at a pH range, such as, a of pH 6.3-6.8. This is because Atkinson provided guidelines for using pH modifiers (see discussions above).
Tseti discloses a stable aqueous composition comprising 10 mg/ml paracetamol and having a pH of 5.5-6.5 (see ¶s 0044-0045, Examples 1-2 and Tables 1-2). By “stable” is meant that the solution can be stored for at least 24 months at room temperature and at least 30 days at elevated temperature (70oC) without appearance of color and particulate matter which is visible to the eye. Please see ¶s 0027, 0036 and stability study at ¶s 0046-004-0049, Examples 3-4 and Tables 3-4).
Tseti discloses that paracetamol in aqueous solution is known to undergo hydrolytic degradation to p-aminophenol, which is also quickly degraded to p-benzoquinoneimine. Tseti discloses that the instability of paracetamol in aqueous medium is shown by the appearance of degradation substances causing a coloring in the solution (see ¶s 0006-0007). Among the causes of paracetamol degradation, Tseti discloses: i) presence of oxygen and/or light; and ii) deacetylation of the amino group generating p-aminophenol, which takes place both at acid pH and (much faster) at basic pH once the phenolate form is present. Please see ¶ 0008.
Among the several joint actions for obtaining stable paracetamol solutions, Tseti discloses:
A) Establishing an optimal pH in which formation of p-aminophenol is prevented or minimized, since it has been reported that hydrolysis of paracetamol is minimized between pH 4.5 and pH 6.0 (see ¶ 0010). The stable aqueous paracetamol solution according to the invention may have a pH between 4.0 and 7.0 (see ¶ 0016);
B) Purging the solution with nitrogen gas to reduce the oxygen (see ¶ 0011 and ¶ 0049, Example 4);
C) Adding at least one stabilizing-dissolving compound and at least one stabilizing compound to the solution (see ¶s 0014-0014, 0018-0020 and Examples 1-2);
D) The solution may further comprise: i) other chelating agents or complexing agents (see ¶ 0022 and Examples 1-2); and ii) isotonic agents (see ¶ 0023 and Examples 1-2).
Tseti discloses that the use of the stabilizing-dissolving and stabilizing compounds according to the invention and preferably the chelating agent has been found to not only increase the paracetamol solubility to the extent that it is possible to dissolve 1000 mg of paracetamol into a final volume of 100 ml but also effectively stabilizes the solution preventing the formation of particulate matter and color at elevated temperature in ampoules, vials and bags. Please see ¶ 0037.
Pavliv discloses clear and colorless aqueous compositions comprising ibuprofen (IBU) at 3.2 mg/ml and having a pH of between 6.34 and 7.40. Pavliv provides guidance for employing appropriate ratio of IBU and solubilizing agents that would generate clear and colorless compositions. Please see Tables 2 and 7-9. The aqueous ibuprofen remains physically and chemically stable in the prefilled bag for intravenous administration for time period suitable to provide a useful shelf-life of the product (e.g., 12 months, 24 months, 36 months, 48 months, 60 months). Please see ¶ 0043. Similar to Atkinson (see title of the invention and abstract) and Tseti (see title of the invention and abstract), Pavliv (see title of the invention, abstract and ¶ 0040), also relates to injectable formulations comprising from about 1 mg/ml to about 100 mg/ml IBU, which can be used in treating conditions such as pain and inflammation.
Regarding claims 2-6 and 15, the claimed pH of 6.3-6.8 and dosage ranges of claims 2.8-3.2 mg/ml ibuprofen in combination with 9.8-10-2 mg/ml paracetamol are art-recognized variables (see discussions above). Therefore, the selection specific solution pH or amount of ibuprofen and paracetamol, would have been routinely determined and optimized in the pharmaceutical art. A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). As recognized by MPEP § 2144.05,
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
For each application of an injectable aqueous composition in the treatment of pain and/or inflammation, the optimum pH and amount of active ingredients employed, can in each case be determined by an artisan of the ordinary skill through test series following the requisite guidelines set forth in the Atkinson, Tseti and Pavliv disclosures discussed above. Factors that would have been taken into consideration when making such a determination would have included, but not have been limited to, the age, weight, sex, medical condition of the patient, severity of the pain and/or inflammation. Thus, the specific pH or ibuprofen and paracetamol concentration that would have actually been employed would have been expected to vary widely and, in the absence of evidence to the contrary, would not have been inconsistent with that which is presently claimed.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Therefore, at the time the instant invention was filed, a person of the ordinary skill in the art would have envisaged a process for making an aqueous composition having a pH of 6.3-6.8 and comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol in the disclosures of Atkinson, Tseti and Pavliv. This is because:
A) Atkinson provided guidelines for using suitable excipients that may include antioxidants, pH modifiers, buffering agents, isotonic agents and water in order to manufacture an aqueous injectable combination composition comprising ibuprofen and paracetamol (see discussions above); and
B) Tseti and Pavliv combined to disclose that each of ibuprofen and paracetamol can be formulated as an aqueous composition at pH ranges encompassing the pH between 6.3 and 6.8, recited in instant claim 1. Please see discussion above.
The skilled artisan would have employed suitable pH modifiers known to those with ordinary skill in the art of formulating intravenous medicines in order to manufacture an aqueous combination composition comprising, for example, 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol, and having a pH of, for example, between 6.3 and 6.8.
The person of the ordinary skill in the art would have had a reasonable expectation that the aqueous combination composition would: i) provide adequate pain relief every 6 hours for some patients that would otherwise need to take higher ibuprofen dose every 8 hours; ii) reduce the risk of undesirable side effects associate with high ibuprofen dosage, without compromising the effectiveness of ibuprofen; and iii) enhance paracetamol stability.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claims 2-6 and 15 are obvious over Atkinson, Tseti and Pavliv.
Regarding claims 5-6, and 10 Atkinson provided guidelines for using suitable excipients that may include antioxidants, pH modifiers, buffering agents, isotonic agents and water in order to manufacture an aqueous injectable composition comprising ibuprofen and paracetamol (see discussions above).
Regarding claims 7-8, and 12, Tseti discloses that at least one stabilizing compound such as cysteine or acetyl cysteine can be employed in formulating the aqueous composition (see ¶ 0020 and reference claim 6).
Regarding claim 13, Tseti discloses disodium phosphate as a buffering agent (see ¶ 0017).
Regarding claim 14, Tseti discloses that paracetamol in aqueous solution is known to undergo hydrolytic degradation to p-aminophenol, which is also quickly degraded to p-benzoquinoneimine. Tseti also discloses causes of paracetamol degradation and provides several joint actions for obtaining stable solutions devoid of degradation products (see discussions above).
Therefore, one skilled in the art would have found it obvious to employ appropriate solution pH and several joint actions for obtaining stable solutions, with a reasonable expectation of arriving at an aqueous composition with little or no degradation products and comprising ibuprofen and paracetamol.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Claims 2 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson (U.S. Pub. No. 20130225685) in view of: i) Tseti (U.S. Pub. No. 20130210922); and ii) Pavliv (U.S. Pub. No. 20130245591), as applied to claims 2 and 10 above, and further in view of: i) Dasberg (U.S. Pub. No. 20120035267, published 02/09/2012); and ii) Dietlin (U.S. Pub. No. 20040054012, published 03/18/2004).
The limitations of claims 2 and 10 as well as the corresponding teachings of Atkinson, Tseti and Pavliv are described above, and hereby incorporated into the instant rejection.
The invention of claims 9 and 11 are similar to claims 2 and 10, however, claims 9 and 11 differ slightly from claims 2 and 10 in that the claims require, wherein: i) the composition has a dissolved oxygen content below 2 ppm (claim 9); and ii) the isotonic agent is mannitol (claim 11).
Although Atkinson, Tseti and Pavliv combine to disclose: i) isotonic agents (see discussions above); and ii) purging the solution with nitrogen gas to reduce the oxygen (see discussions above), the Atkinson, Tseti and Pavliv differ from claims 9 and 11 only insofar as the cited references do not combine to explicitly disclose limitations of claims 9 and 11.
However, the claim inventions would have been obvious over Atkinson, Tseti and Pavliv. This is because, at the time of the instant invention it was known in the art that: i) aqueous formulations comprising oxidation-sensitive active ingredients (e.g., paracetamol), can be deoxygenated to below 2 ppm of oxygen content by bubbling with inert gas such as nitrogen; and ii) mannitol was known among suitable isotonic agents. For example:
i) Dietlin discloses deoxygenation of aqueous formulations comprising oxidation-sensitive active ingredients (e.g., paracetamol, see ¶s 0003 and 0011), to below 2 ppm, carried out by bubbling with inert gas such as nitrogen (see ¶s 0013-0015 and 0030). Similar to Tseti (see discussions above), among the disadvantages of secondary products formed by oxidative degradation of active agents in aqueous solution, Dietlin discloses: i) loss of activity or the production of allergenic products; ii) uncontrollable reduction in the concentration of active agents; and iii) formation of colored compounds, thus making the aqueous solution unsuitable for therapeutic applications. Please see ¶s 0004-0007. Dietlin also discloses: i) cysteine (see
¶
0062); and ii) mannitol (see
¶
0044).
ii) Dasberg discloses mannitol among suitable isotonic agents that are known to a person of the ordinary skill in the art (see ¶ 0052). Similar to Atkinson, Tseti and Pavliv, Dasberg relates to aqueous formulations comprising paracetamol (see abstract and ¶ 0001).
Therefore, at the time the instant invention was filed, one of the ordinary skill in the art would have found it obvious to modify Atkinson, Tseti and Pavliv with Dasberg and Dietlin in order to arrive at the invention of claims 9 and 11. A person of the ordinary skill would have had a reasonable expectation that that the aqueous composition comprising ibuprofen, paracetamol and further comprising an isotonic agent (e.g., mannitol), would exhibit utility in the treatment of a disease condition such as pain and/or inflammation. The skilled artisan would also have had a reasonable expectation that that the deoxygenation of an aqueous combination composition comprising ibuprofen and paracetamol, to below 2 ppm, would results in an enhanced composition stability.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Non-Statutory Obviousness-Type 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent NO.11,389,416 (‘416 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the claims of ‘416 patent are similarly drawn to an aqueous composition comprising ibuprofen and paracetamol. For example, the claims of the instant application (e.g., claim 2), are drawn to a method for preparing an aqueous composition at pH of 6.3 to 6.8, and comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol, whereas, the claims of the ‘419 patent (e.g., claim 1), are directed to aqueous composition at pH of 6.3 to 6.8, and comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Claims 2-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent NO.11,213,498 (‘498 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the claims of ‘416 patent are similarly drawn to an aqueous composition comprising ibuprofen and paracetamol. For example, the claims of the instant application (e.g., claim 2), are drawn to a method for preparing an aqueous composition at pH of 6.3 to 6.8, and comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol, whereas, the claims of the ‘498 patent (e.g., claim 1), are directed to aqueous composition at pH of 6.3 to 6.8, and comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Claims 2-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent NO.11,219,609 (‘609 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the claims of ‘609 patent are similarly drawn to a method for preparing an aqueous composition comprising ibuprofen and paracetamol. For example, the claims of the instant application (e.g., claim 2), require dissolving ibuprofen and paracetamol in an aqueous solution, whereas the claims of the ‘609 patent (e.g., claim 1) require providing an aqueous solvent and dissolving ibuprofen and paracetamol in the aqueous solvent.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Claims 2-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent NO.12,083,087 (‘087 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the claims of ‘087 patent are similarly drawn to a an aqueous composition comprising ibuprofen and paracetamol. For example, the claims of the instant application (e.g., claim 2), are drawn to a method for preparing an aqueous composition comprising ibuprofen and paracetamol, whereas, the claims of the ‘609 patent (e.g., claim 1), are directed to a method for treating pain with an aqueous composition comprising ibuprofen and paracetamol.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Claims 2-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent NO.11,413,241 (‘241 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the claims of ‘241 patent are similarly drawn to a method for preparing an aqueous composition comprising ibuprofen and paracetamol. For example, the claims of the instant application (e.g., claim 2), require dissolving ibuprofen and paracetamol in an aqueous solution, whereas the claims of the ‘241 patent (e.g., claims 1 and 11) are directed to a method for preparing an aqueous composition comprising ibuprofen and one or more NSAID (e.g., paracetamol).
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights