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 .
DETAILED ACTION
Reissue: Non-Final Office Action
Status of the Claims
Claims 4-12 are currently pending and are the subject of this Office Action. Claims 4-12 are newly presented in the instant reissue application. This is the first Office Action on the merits of the claims in reissue Application No. 18/100,024.
Procedural Posture
On 4/9/2019: US Patent 10,251,848 issued to Mitidieri et al. with claims 1-3.
On 8/30/2020: Applicants filed US Reissue Patent Applications 17/006,838, 17/006,840, and 17/006,841 for US Patent 10,251,848.
On 1/23/2023: Applicants filed US Reissue Patent Application 18/100,024 (the instant application) for US Patent 10,251,848.
On 2/21/2023: US Patent 10,251,848 was reissued as US RE49,422 from reissue application 17/006,840.
On 3/7/2023: US Patent 10,251,848 was reissued as US RE49,443 from reissue application 17/006,838.
On 6/20/2023: US Patent 10,251,848 was reissued as US RE49,555 from reissue application 17/006,841.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 10,251,848 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Information Disclosure Statement
References lined-through on the information disclosure statement(s) were not considered because they were not provided. MPEP § 1406 states that in reissue applications references that have been cited during original prosecution of the patent are considered. However. should applicants wish to ensure that all of the references which were cited in the original patent are considered and cited in the reissue application, an information disclosure statement (IDS) in compliance with 37 CFR 1.97 and 1.98 should be filed in the reissue application. Note that 37 CFR 1.98 requires copies of foreign patents and other (e.g., NPL) publications to be provided. No such copies were provided with the instant reissue application.
It is noted that the names provided for references 1-4 and 6 listed on the IDS do not match the pre-grant publication numbers provided. The documents having the provided publication numbers were considered, but do not appear relevant to the instant case.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was 2/14/2023.
Related Patents’ Specifications
The examiner notes that the specifications of related reissued patents RE49,422 (from reissue application 17/006,840), RE49,443 (from reissue application 17/006,838), and RE49,555 (from reissue application 17/006,841) do not reflect the instant reissue application and should therefore be amended by certificates of correction. See 37 CFR 1.177(a); If applicant files more than one application for the reissue of a single patent, each such application must contain or be amended to contain in the first sentence of the specification a notice stating that more than one reissue application has been filed and identifying each of the reissue applications by relationship, application number and filing date. MPEP 1451(I) (“The examiner should object to the specification and require an appropriate amendment if applicant fails to include such a cross reference to the other reissue applications in the first sentence of the specification of each of the reissue applications.”).
Defective Declaration/Oath
The reissue oath/declaration filed with this application is defective because it fails to identify at least one error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414.
A. It is unclear why the original patent is wholly or partially inoperative or invalid because the patentee claimed less than he had the right to claim in the patent. The amendment to claim 1 broadens the claim (e.g., removing the lower limit on the claimed range of noradrenaline, removing the requirement that the solvent is water, and removing the requirement that the solution is free of anti-oxidizing agents), but patentee does not detail specifically why these amendments are necessary because the original patent was wholly or partially inoperative or invalid. See MPEP § 1414 I and II, which state, in relevant part:
What is needed for the oath/declaration statement as to error is the identification of “at least one error” relied upon. For an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must also identify a claim that the application seeks to broaden. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.
It is not sufficient for an oath/declaration to merely state "this application is being filed to correct errors in the patent which may be noted from the changes made in the disclosure." Rather, the oath/declaration must specifically identify an error. In addition, it is not sufficient to merely reproduce the claims with brackets and underlining and state that such will identify the error. See In re Constant, 827 F.2d 728, 729, 3 USPQ2d 1479 (Fed. Cir.), cert. denied, 484 U.S. 894 (1987). Any error in the claims must be identified by reference to the specific claim(s) and the specific claim language wherein lies the error.
A statement in the oath/declaration of "…failure to include a claim directed to…" and then reciting all the limitations of a newly added claim, would not be considered a sufficient "error" statement because applicant has not pointed out what the other claims lacked that the newly added claim has, or vice versa. Such a statement would be no better than saying in the reissue oath or declaration that "this application is being filed to correct errors in the patent which may be noted from the change made by adding new claim 10." In both cases, the error has not been identified.
Although applicants state that independent claim 1 is broadened to cover “formulations having noradrenaline concentrations less than 0.2 mg/ml,” this explanation is not sufficiently specific as it does not identify a single word, phrase, or expression in the specification or in an original claim and how it renders the original patent wholly or partly inoperative or invalid. Applicants have not pointed out what the original claims lacked that the newly added claim(s) has, or vice versa. Applicants are advised that they must be specific in pointing out these differences (i.e., the new or deleted features) and in explaining how they broaden the claims.
B. The declaration filed with this application identifies the error as: “Independent claim 1 is broadened to cover formulations having noradrenaline concentrations less than 0.2 mg/ml”. This is not an error upon which reissue can be based because reissue application 17/006,840 (now RE49,422; parent of this reissue) stated the same error as the basis for reissue.
MPEP 1451(I)(B)(2) instructs, “If the copy of the oath/declaration does not cover an error being corrected by the continuing reissue application, the examiner should reject the claims of the continuing reissue application under 35 U.S.C. 251 as being based on an oath/declaration that does not identify an error being corrected by the continuing reissue application.” See also MPEP 1414(II)(D). It is not clear from the declaration in this application that the error identified is being corrected in a different way from the parent application, which corrected the same error. For example, in parent patent RE49,422, independent claim 4 recites a stable injectable noradrenaline solution wherein the concentration of noradrenaline is less than or equal to 0.2 mg/ml.
This error identified in the current application’s reissue declaration has already been corrected in the previous reissue application, so it cannot form the basis for reissue here. A new oath/declaration that identifies a new error or a statement explaining compliance with 37 CFR 1.175(f)(2) is required.
CLAIM REJECTIONS - 35 USC § 251
Claims 4-12 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office Action.
Broadening Reissue
The instant reissue application is a CON of 17/006,840, also a reissue application. Parent application 17/006,840 was filed on 8/30/2020, which is within two years of the issue date of US Patent 10,251,848 (issued on 4/9/2019); has a broadened claim (e.g., ’840 claim 1); and has clear intent to broaden the claim. The instant reissue application likewise has a claim broader than a claim in the original patent (e.g., instant claim 1), and has a clear intent to broaden the claim.
Claims 4-12 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
A broadening aspect is present in the reissue application which was not present in the patent under reissue. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984).
In accordance with MPEP 1412.02 (and case law cited therein) we apply the recapture rule as a three-step process:
(1) Determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims.
(2) Determine whether the broader aspects of the reissue claims related to subject matter surrendered in the original prosecution; and
(3) Determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In the instant case,
(1) Reissue claims 4-12 are broader in scope than the original patent claims.
Original claim 1 required, inter alia, a stable injectable noradrenaline solution having degassed or deaerated water as a solvent, wherein the solution is free of preservatives and anti-oxidizing agents. Claims 4 and 7 of the reissue have broadened these aspects by removing the requirement that the solvent is water ("the solvent is degassed or deaerated") and removing the requirement that the solution is free of anti-oxidizing agents (for claim 4; "wherein the solution is free of preservatives and complexing agents") or removing the requirement that the solution is free of both preservatives and anti-oxidizing agents (for claim 7).
(2) The broader aspect of the reissue of claims 4-12 is related to subject matter surrendered in the original prosecution.
Claims 4-12 do not require that the claimed composition be free of anti-oxidizing agents. Review of original application 15/118,864 shows that applicant amended claim 9 (which became issued claim 1) to recite that the solution is "free of preservatives and anti-oxidizing agents" in the response filed 6/8/2018. Furthermore, applicant argued that this feature distinguished over the prior art (remarks filed 6/8/2018, pgs. 5-6). Specifically, applicant argued the absence of preservatives and anti-oxidizing agents improves the safety of the claimed noradrenaline solution and avoids the occurrence of known side effects or allergic reaction when the organism is already under stress (see the par. bridging pgs. 5-6 of the 6/8/2018 response).
Applicants also stated that the surprising and unexpected features derived from degassed or deaerated water as solvent (see par. 17 of the declaration, and p. 4 (middle) of the arguments filed 1/26/2018 in 15/118,864). The surprising and unexpected properties were relied upon to secure allowance of the original claims (see pars 24-41 of the declaration, and pgs. 5-12 of the arguments filed 1/26/2018 in 15/118,864).
(3) There is no evidence of record that the reissue claims were materially narrowed in other respects so that the claims may not have been enlarged, and hence avoid the recapture rule.
Independent claims 4 and 7 do not any new features that might materially narrow the scope of these claims. See MPEP 1412.02(Il). Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over BAILLIE (US 2012/0129944; Pub. May 24, 2012) in view of TREMBLAY (Tremblay, M., et al. Can. J. Anesth. (2008), 55(3); 163-167).
Baillie discloses methods for making stabilized compositions (injectable solutions) comprising adrenergic compounds (title; abstract; [0081]; Example 1). The adrenergic compound may be norepinephrine (noradrenaline) or a physiologically acceptable salt thereof such as a tartrate ([0053]-[0055], [0057], [0103]). The pH of the solution is between 3.3-3.5, preferably 3.4, to optimize stability ([0067]-[0068]). Baillie teaches that adrenergic compounds are susceptible to degradation by auto-oxidation ([0068]). For this reason, it would have been obvious to formulate the solution entirely with degassed water (typically produced by purging water with an inert gas such as nitrogen) and further process it in inert gas, in order to avoid the introduction of oxygen and prevent auto-oxidation. The working example, a solution of epinephrine tartrate, was prepared (at least in part) with degassed water and NaCl ([0089]-[0090]; claim 11). Baillie exemplifies the use of HCl to adjust the pH to achieve a pH of 3.4 (Example 1). Baillie does not teach the use of preservatives, and teaches that there is no advantage in using a chelating (complexing) agent are more stable than those containing them ([0100]; Figs. 1-2).
Baillie does not disclose solutions having noradrenaline at concentrations less than or equal to 0.2 mg/ml.
Tremblay teaches that noradrenaline is frequently used at concentrations of 0.004 mg/ml or 0.016 mg/ml, diluted from a solution comprising 1 mg/ml noradrenaline bitartrate, NaCl and sterile water (p. 164 col. 2).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to produce a solution with a lower concentration of noradrenaline, since concentrations of 0.004 mg/ml and 0.016 mg/ml are commonly used as taught by Tremblay.
Claim 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over BAILLIE in view of TREMBLAY as applied to claims 4 and 7 above, and further in view of COROSYS (Vacuum Water Deaeration; accessed online 5/14/2025 at https://cpt.corosys.com/en/products/degassing-absorption/degassing-vacuum-water-solvent.php; website Available by Apr. 2010).
The teachings of Baillie and Tremblay are presented supra and are incorporated herein. Baillie teaches degassed water for injection ([0090]), but does not expressly describe the oxygen content thereof.
Corosys discloses a high-vacuum system for degassing water for use in the pharmaceutical industry. The system deaerates water to a residual oxygen concentration below 10 ppb. Corosys teaches a number of advantages for this system, including low energy consumption, zero greenhouse gas emissions, and easy operation. See the entire document.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to deaerate the water as taught by Baillie to a residual oxygen concentration of less than 100 ppb. One would be motivated to do so since advantageous systems capable of achieving less than 10 ppb oxygen were known and available at the time of the invention, as evidenced by Corosys.
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over BAILLIE in view of TREMBLAY as applied to claims 4 and 7 above, and further in view of JORNITZ (Jornitz, M. W. Pharm. Tech. Europe (2011), 23(1)).
The teachings of Baillie and Tremblay are presented supra and are incorporated herein.
Claims 8 and 11 are product-by-process claims. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113. Claim 8 is drawn to a method of preparing and packaging a noradrenaline solution into containers. The substance and structure of the claimed noradrenaline solution is not affected by this limitation, which merely reflects one version of a process that could be used to make and package the product. The solution could be made in other ways, thus, the process limitations do not add patentable weight to the claim. If the product in this claim is the same as or obvious from a product of the prior art, the claim is unpatentable.
Sterilizing the solutions is the only structural limitation imparted by the process steps of claims 8 and 11. While anyone of skill in this art would understand that solutions for injection must be prepared in a sterile fashion, the references do not explicitly teach sterilizing the solutions.
Jornitz teaches, “Biopharmaceuticals commonly cannot be terminally sterilised, as such aseptic processing using sterilising grade filtration is essential. Heat sterilisation, or any energetic input into biotech drug products, causes undesired product degradation so the only available option is sterilised filtration of the biopharmaceutical fluid. Sterilising membrane filtration has been used for decades, and there is a very high experience and expertise level within the industry.” See p. 1.
It would have been obvious to modify the methods and compositions of Baillie by sterile filtering the solution, which is routine practice for pharmaceuticals as taught by Jornitz. It would also have been obvious to package the sterilized solution in a sealed container to maintain sterility and exclude oxygen.
Baillie in view of Tremblay renders obvious the solution of claim 7. Baillie further teaches packaging the injectable solutions in sealed ampoules ([0048], [0080]; claim 15). Thus claim 8 is rejected as unpatentable over Baillie and Tremblay.
Claims 4, 7, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over DINNEQUIN (US 2005/0070613; Pub. Mar. 31, 2005) in view of BAILLIE (US 2012/0129944; Pub. May 24, 2012).
Dinnequin discloses “stabilized antioxidant-free solutions based on phenolic substances” (title; abstract). In particular, “wherein the phenolic substance is noradrenaline at a dose of 0.2 mg/ml” (claim 11; see also [0049]: “preservative-free noradrenaline solution at 0.025% and 0.1% packaged in 1 ml, 5 ml and 10 ml ampoules”; and [0089]: “Noradrenaline 0.2% (w/v) injection”) — wherein “the active principle and... the possible excipients such as sodium chloride [are dissolved] in water... previously degassed by nitrogen bubbling until a residual dissolved oxygen content lower or equal to 0.02 ppm” ([0027]), followed by “[a]djustment of the pH” ([0029]), more specifically “with pH adjusted above 3.0 and below 5.0” (Abstract). Dinnequin teaches the advantage of avoiding the use of preservatives, antioxidants, and complexing agents ([0002], [0016]).
As such, the stable injectable noradrenaline solution taught by Dinnequin differs from that instantly claimed in that the pH of Dinnequin’s solutions is between above 3.0 and below 5.0, whereas the pH of the instantly claimed solutions is from 3.3 to 3.6 “by hydrochloric acid”.
Baillie discloses methods for making compositions (injectable solutions) comprising adrenergic compounds (title; abstract; [0081]; Example 1). The adrenergic compound may be norepinephrine (noradrenaline) or a physiologically acceptable salt thereof such as a tartrate ([0053]-[0055], [0057], [0103]). The pH of the solution is between 3.3-3.5, preferably 3.4, to optimize stability ([0067]-[0068]). Baillie teaches that adrenergic compounds are susceptible to degradation by auto-oxidation ([0068]). For this reason, it would have been obvious to formulate the solution entirely with degassed water (typically produced by purging water with an inert gas such as nitrogen) and further process it in inert gas, in order to avoid the introduction of oxygen. The working example, a solution of epinephrine tartrate, was prepared (at least in part) with degassed water and NaCl ([0089]-[0090]; claim 11). Baillie exemplifies the use of HCl to adjust the pH to achieve a pH of 3.4 (Example 1). Baillie does not teach the use of preservatives, and teaches that there is no advantage in using a chelating (complexing) agent are more stable than those containing them ([0100]; Figs. 1-2) Baillie does not disclose solutions having noradrenaline at concentrations less than or equal to 0.2 mg/ml.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to adjust the pH of the solutions to 3.4, to optimize stability as taught by Baillie. One would also have found it obvious to use HCl to adjust the pH since Baillie teaches this as a suitable reagent for this purpose.
Claims 8 and 11 are product-by-process claims as discussed in the rejection over Baillie and Tremblay. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Dinnequin teaches sterilizing the solution and packaging in sealed ampoules (abstract; [0007], [0027], [0034]-[0035], [0049]; claims 1, 8).
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over DINNEQUIN in view of BAILLIE as applied to claims 4, 7, 8, and 11 above, and further in view of COROSYS (Vacuum Water Deaeration; accessed online 5/14/2025 at https://cpt.corosys.com/en/products/degassing-absorption/degassing-vacuum-water-solvent.php; website Available by Apr. 2010).
The teachings of Dinnequin and Baillie are presented supra and are incorporated herein. Dinnequin teaches degassed water for injection having an oxygen content lower than 0.02 ppm ([0005], [0023]). While this teaching encompasses the claimed amount of lower than 100 ppb, Corosys is cited in the interest of compact prosecution and customer service.
Corosys discloses a high-vacuum system for degassing water for use in the pharmaceutical industry. The system deaerates water to a residual oxygen concentration below 10 ppb. Corosys teaches a number of advantages for this system, including low energy consumption, zero greenhouse gas emissions, and easy operation. See the entire document.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to degass the water as taught by Dinnequin to a residual oxygen concentration of less than 100 ppb. One would be motivated to do so since advantageous systems capable of achieving less than 10 ppb oxygen were known and available at the time of the invention.
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 obviousness-type 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); and 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
US Patent RE49,422
Claims 4-12 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 4-19 of US Patent RE49,422. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '422 claims anticipates or renders obvious that of the instant claims. '422 claim 4 recites a stable injectable noradrenaline solution comprising noradrenaline (or a salt thereof), a solvent, an excipient, and hydrochloric acid, the noradrenaline concentration is 0.2 mg/ml, the solvent consists of degassed or deaerated water, the excipient is NaCl, and the pH is in the range from 3.3 to 3.6, and the solution is free of preservatives, anti-oxidizing agents, and complexing agents. '422 claim 4 thus anticipates instant claim 4.
Regarding instant claim 5, '422 claim 6 recites the oxygen content of the solvent is lower than 100 ppb.
Regarding instant claim 6, '422 claim 7 recites the same level of impurities instantly recited.
Regarding instant claim 7, '422 claims 12-13 recite noradrenaline bitartrate.
Regarding instant claim 8, '422 claims 5 and 13 recite the solution in a sealed container obtained by the same process steps (a)-(e) instantly claimed.
Regarding instant claim 9, '422 claim 14 recites the oxygen content of the solvent is lower than 100 ppb.
Regarding instant claim 10, '422 claim 15 recites the same level of impurities instantly recited.
Regarding instant claim 11, '422 claim 16 recites filtrating during step (c) of claim 13.
Regarding instant claim 12, '422 claim 18 recites the same level of impurities instantly recited.
US Patent RE49,443
Claims 4-12 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-25 of US Patent RE49,443. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '443 claims anticipates or renders obvious that of the instant claims. '443 claim 4 recites a stable injectable noradrenaline solution comprising noradrenaline (or a salt thereof), a solvent, an excipient, and hydrochloric acid, the noradrenaline concentration is from 0.04 to 0.2 mg/ml, the solvent consists of degassed or deaerated water, the excipient is NaCl, and the pH is in the range from 3.3 to 3.6, and the solution is free of preservatives, anti-oxidizing agents, and complexing agents. '422 claim 4 thus anticipates instant claim 4.
Regarding instant claim 5, '443 claim 6 recites the oxygen content of the solvent is lower than 100 ppb.
Regarding instant claim 6, '443 claim 8 recites the same level of impurities instantly recited.
Regarding instant claim 7, '443 claims 17-18 recite noradrenaline bitartrate.
Regarding instant claim 8, '443 claims 5 and 13 recite the solution in a sealed container obtained by the same process steps (a)-(e) instantly claimed.
Regarding instant claim 9, '443 claims 3 and 6 recite the oxygen content of the solvent is lower than 100 ppb.
Regarding instant claim 10, '443 claims 14 and 16 recite the same level of impurities instantly recited.
Regarding instant claim 11, '443 claims 5 and 9 recite filtrating during step (c).
Regarding instant claim 12, '443 claims 14 and 16 recites the same level of impurities instantly recited.
US Patent RE49,555
Claims 4-12 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-25 of US Patent RE49,555 in view of Baillie. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '555 claims anticipates or renders obvious that of the instant claims. '555 claim 4 recites a container of a preservative free, anti-oxidant-free, injectable noradrenaline bitartrate solution made by a process comprising: a) dissolving noradrenaline bitartrate in deoxygenated degassed water, b) adjusting the pH with HCl to a value from 3.3 to 3.6, c) filtrating, d) distributing the solution into containers, and e) sterilizing. '555 claim 5 recites the solution is free of complexing agents as well as preservatives, and recites a noradrenaline concentration of less than 0.2 mg/ml. The only difference between the '555 claims and the instant claims is that the '555 claims do not expressly recite NaCl as the excipient.
However, Baillie discloses methods for making stabilized compositions (injectable solutions) comprising adrenergic compounds (title; abstract; [0081]; Example 1). The adrenergic compound may be norepinephrine (noradrenaline) or a physiologically acceptable salt thereof such as a tartrate ([0053]-[0055], [0057], [0103]). The pH of the solution is between 3.3-3.5, preferably 3.4, to optimize stability ([0067]-[0068]). Baillie teaches that adrenergic compounds are susceptible to degradation by auto-oxidation ([0068]). For this reason, it would have been obvious to formulate the solution entirely with degassed water (typically produced by purging water with an inert gas such as nitrogen) and further process it in inert gas, in order to avoid the introduction of oxygen and prevent auto-oxidation. The working example, a solution of epinephrine tartrate, was prepared (at least in part) with degassed water and NaCl ([0089]-[0090]; claim 11). Baillie exemplifies the use of HCl to adjust the pH to achieve a pH of 3.4 (Example 1). Baillie does not teach the use of preservatives, and teaches that there is no advantage in using a chelating (complexing) agent are more stable than those containing them ([0100]; Figs. 1-2). Thus, Baillie renders obvious the use of NaCl in injectable noradrenaline solutions.
Regarding instant claim 5, '555 claim 5 recites the oxygen content of the solvent is lower than 100 ppb.
Regarding instant claim 6, '555 claim 6 recites the same level of impurities instantly recited.
Regarding instant claim 7, '555 claim 4 recites noradrenaline bitartrate.
Regarding instant claim 8, '555 claims 4 and 13 recite the solution in a container obtained by the same process steps (a)-e)) instantly claimed. The recitation in '555 claim 4 of in the substantial absence of air or oxygen implies the container is sealed.
Regarding instant claim 9, '555 claims 5 and 6 recite the oxygen content of the solvent is lower than 100 ppb.
Regarding instant claim 10, '555 claims 5 and 6 recite the same level of impurities instantly recited.
Regarding instant claim 11, '555 claims 4 and 6 recite filtrating during step (c).
Regarding instant claim 12, '555 claims 5 and 6 recite the same level of impurities instantly recited.
Conclusion
Claims 4-12 are rejected. No claims are currently allowable.
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/Kevin S Orwig/
Patent Reexamination Specialist
Art Unit 3991
Conferees:
/Lora E Barnhart Driscoll/Patent Reexamination Specialist, Art Unit 3991
/T.M.S/Supervisory Patent Examiner, Art Unit 3991