DETAILED ACTION
This office action is in response to applicant’s filing dated July 7, 2026.
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 Claims
Claims 3, 6, 9-11, 13-19, 21-23, 25-27, 29, 34, 36, 37, 39, 40, 43-46, 48, 49, 51, 54, 55, 57, 68-71, 73, and 74 are pending in the instant application. Acknowledgement is made of Applicant's amendments and remarks filed July 7, 2026. Acknowledgement is made of Applicant's amendment of claims 3, 6, 9, 21, 34, 43-46, 48, 54, and 68; cancelation of claims 1, 2, 4, 5, 7, 8, 12, 20, 24, 28, 30-33, 35, 38, 41, 42, 47, 50, 52, 53, 55, 56, 58-67, and 72; and addition of new claims 73 and 74.
Applicants elected without traverse a formulation species comprising an insulin analogue, insulin aspart; an non-ionic surfactant, dodecyl maltoside; tonicity modifying agent, sodium chloride; phosphate buffer; a preservative, m-cresol; wherein the formulation is substantially free of zinc binding species having a logK with respect to zinc ion binding of 10-12.3 at 25°; does not contain a vasodilator; and does not contain an additional therapeutically active agents in the reply filed on August 25, 2025. The requirement is still deemed proper. Claims 11, 27, 29, 37, 39, 51, and 57 remain withdrawn.
New claims 73 and 74 read on the elected species and thus are presently under examination.
Claims 3, 6, 9, 10, 13-19, 21-23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are presently under examination as they relate to the elected species: insulin aspart, dodecyl maltoside, sodium chloride, phosphate buffer, m-cresol; wherein the formulation is substantially free of zinc binding species having a logK with respect to zinc ion binding of 10-12.3 at 25°; does not contain a vasodilator; and does not contain an additional therapeutically active agents.
Priority
The present application is a 371 of PCT/GB2021/050815 filed on April 1, 2021, which claims benefit of foreign priority to UNITED KINGDOM 2004814.6 filed on April 1, 2020.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 112(b)
Indefinite
The rejection of claims 8, 9, 34, 43, 45, 46, 48, and 54 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 has been rendered moot in view of the cancelation of claim 8 and amendment of claims 9, 34, 43-46, 48, and 54. Thus, the rejection has been withdrawn.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 6, 9, 10, 13-19, 21-23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The Written Description Guidelines for examination of patent applications indicates, “the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show applicant was in possession of the claimed genus.” (Federal register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3) and (see MPEP 2164).
In the instant case, instant claims 3, 6, and 9 are directed to a method of treating a human subject suffering from diabetes mellitus by administration of an aqueous liquid pharmaceutical formulation comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate; said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C, wherein said administration is by subcutaneous injection or subcutaneous infusion at or close to a meal-time wherein the administration of 0.3 U/kg of the formulation leads to the claimed pharmacokinetics. Dependent claim 43 is directed to additional pharmacodynamic properties of ionic strength of the composition. Dependent claims 68-70 are directed to stability properties of the claimed formulation.
Dependent claim 10 further limits the insulin analogue to insulin aspart. Dependent claims 13-17, 19, 34, and 74 further limit the amounts of insulin analogue, zinc, citrate, or non-ionic surfactant in the compositions. Dependent claim 18 further limits the citrate to citric acid. Dependent claims 22, 23, 25, and 26 further limits the composition to further comprise non-ionic surfactant, dodecyl maltoside. Dependent claims 36 and 40 further limits the composition to further comprise a tonicity modifying agent, sodium chloride. Dependent claims 45, 46 further limits the pH of the composition. Dependent claim further limits the composition to comprise a phosphate buffer. Dependent claim 49 further limits the composition to further comprise a preservative. Dependent claims 54 and 74 further limit the composition to exclude the presence of a vasodilator. Dependent claim 71 further limits the method to a specific dosing regimen.
The phrase “an aqueous liquid pharmaceutical formulation comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C” is open ended and as such, it does not exclude any other ingredients from being present together with the insulin analogue, ionic zinc and citrate. As such, the claims are being interpreted as: a mixture or composition comprising insulin analogue, ionic zinc, and citrate limited by certain physicochemical properties which does not exclude the presence of other components.
Therefore, the claims encompass a genus of compositions defined by its physicochemical properties, which is simply a wish to know the identity of such composition that will satisfy those physicochemical properties. Accordingly, there is insufficient written description encompassing: “insulin analogue, ionic zinc and citrate” wherein the administration of the composition achieves one or more of the claimed pharmacokinetic properties as disclosed in claims 3, 6, 9, 43, and 68-70, because the relevant identifying characteristics of the genus such as structure or other physical and/or chemical characteristics of “a mixture or composition comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C” which “the subcutaneous injection or infusion of the composition achieves one or more of the claimed pharmacokinetic properties” as disclosed in claim 3, 6, 9, 43, and 68-70 are not set forth in the specification as-filed, commensurate in scope with the claimed invention. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (see Vas-Cath at page 1116).
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddles v. Baird, 30 USPQ2d 1481, 1483. In Fiddles v. Baird, claims directed to mammalian FGF’s were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Thus, the specification fails to describe these DNA sequences. The Court further elaborated that generic statements are not adequate written description of the genus because it does not distinguish the claimed genus from others, except by function.
Per the Enzo court’s example, (Enzo Biochem., Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched “in terms of its function of lessening inflammation of tissues” which, the court stated, “fails to distinguish any steroid from others having the same activity or function” and the expression “an antibiotic penicillin” fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, “(i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C” wherein the subcutaneous injection of the composition achieves one or more of the claimed pharmacokinetic properties as disclosed in claim 3, 6, 9, 43, and 68-70, does not distinguish any particular composition comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C from other compositions having the same activity or function and as such does not satisfy the written-description requirement. Applicant has not disclosed enough relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
M.P.E.P. 2163 II-A-3-a ii) states: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i) (C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)(Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)”.
In the instant case, Applicants disclose 1 composition comprising insulin aspart, sodium phosphate, citric acid, sodium chloride, dodecyl maltoside, m-cresol, phenol, water, and sodium hydroxide to adjust the pH to 7.4 which achieves the claimed pharmacological properties (Table 1-7).
Given the broad scope of the claimed subject matter (the large genus of compositions comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that might satisfy the instantly claimed pharmacological properties), applicant has not provided sufficient written description that would allow the skilled artisan to recognize that applicant was in possession of the genus of “a composition comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C” wherein the formulation achieves one or more of the claimed pharmacokinetic properties as disclosed in claims 3, 6, 9, 43, and 68-70.
In the absence of structural characteristics that are shared by members of the genus of “a composition comprising(i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C” wherein the formulation achieves one or more of the claimed pharmacokinetic properties as disclosed in claims 3, 6, 9, 43, and 68-70, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus. See University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997).
In summary, the skilled in the art will not know which other components (if any) and in which proportion should be present in the claimed composition besides (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C in order to satisfy the claimed release profile, ionic strength, and storage stability.
Response to Arguments
Applicant argues:
The specification, when viewed through the lens of a person of skill in the art, provides a clear and enabling disclosure of the claimed invention. At the time of filing, the level of skill in the art of insulin formulation and diabetes treatment was high. A person of skill in the art would have been intimately familiar with the hexameric nature of insulin and the established techniques for destabilizing these hexamers, such as amino acid substitutions in insulin analogues or the use of zinc-chelating agents, to achieve faster onset of action. The specification leverages this high level of background knowledge and skill by providing specific, technically accurate parameters that define the claimed methods, such as the use of fast-acting analogues like insulin aspart, lispro, and glulisine. By identifying the specific combination of (i) a fast-acting insulin analogue, (ii) ionic zinc, and (iii) citrate, and further defining the exclusion of high-affinity zinc-binding species (logK > 12.3), the inventors have provided a structural "roadmap" that a skilled artisan would recognize as being in the inventors' possession. Furthermore, the written description is bolstered by the disclosure of precise physicochemical boundaries that dictate the formulation's performance. The application does not merely claim a result; it describes the specific ionic strength calculations, the required concentrations of surfactants and tonicity agents needed to maintain stability while achieving ultra- rapid absorption. The specification further provides a wide variety of species across Examples A-R, covering different concentrations (100 U/ml to 200 U/ml), multiple buffer systems, and various tonicity modifiers. These examples, supported by the detailed clinical data in Tables 1-7, demonstrate that the functional pharmacokinetic and pharmacodynamic thresholds, such as the area under the glucose infusion rate curve (AUCGIR0-30) of at least 14 mg/kg, are a predictable result of the disclosed structural features. Given the high level of skill in the art and the extensive experimental evidence provided, the specification more than adequately conveys possession of the claimed genus.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, the claims encompass a genus of compositions defined by its physicochemical properties. As set forth above, there is insufficient written description encompassing: “insulin analogue, ionic zinc and citrate” wherein the administration of the composition achieves one or more of the claimed pharmacokinetic properties as disclosed in claims 3, 6, 9, 43, and 68-70, because the relevant identifying characteristics of the genus such as structure or other physical and/or chemical characteristics of “a mixture or composition comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (iii) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C” which “the subcutaneous injection or infusion of the composition achieves one or more of the claimed pharmacokinetic properties” as disclosed in claim 3, 6, 9, 43, and 68-70 are not set forth in the specification as-filed, commensurate in scope with the claimed invention. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (see Vas-Cath at page 1116).
It is well known and understood in the art of formulation chemistry that pharmacodynamic properties such as those of the instant claims are highly dependent on the components present and the amounts of the components present in the composition. Most of the claims are very broad in terms of any insulin analogue, any ionic zinc source, and any citrate without limit encompassed by the instant claims. Applicants disclose 1 composition comprising insulin aspart, sodium phosphate, citric acid, sodium chloride, dodecyl maltoside, m-cresol, phenol, water, and sodium hydroxide to adjust the pH to 7.4 which achieves the claimed pharmacological properties (Table 1-7). Thus, Applicants disclose a single composition with specific ingredients that is able to achieve the claimed properties. A single composition is insufficient to provide written description support for the full scope of compositions encompassed by the instant claims. In summary, the skilled in the art will not know which other components (if any) and in which proportion should be present in the claimed composition besides insulin aspart, sodium phosphate, citric acid, sodium chloride, dodecyl maltoside, m-cresol, phenol, water, and sodium hydroxide to adjust the pH to 7.4, in order to satisfy the claimed release profile, ionic strength, and storage stability.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3, 6, 9, 10, 13-19, 21-23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerring et al (WO 2018/060735 A1, cited in the IDS filed September 30, 2022).
Regarding claims 3, 6, 9, and 68-70, Gerring teaches a method of treatment of diabetes mellitus comprising administering to a subject in need thereof an effective amount of a formulation (claim 49), wherein the formulation is an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc; (iii) a zinc binding species having a logK with respect to zinc ion binding in the range of 4.5-12.3 at 25°C; and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a IogK with respect to zinc ion binding of more than 12.3 at 25 °C (claim 1); wherein the zinc binding species is citrate (claims 14 and 15). Gerring teaches an exemplary formulation contains insulin at a concentration of 100 U/ml (page 8, lines 12-14).
Gerring further teaches Example F comprises:
Insulin aspart 100 U/ml
Sodium phosphate 2 mM
Phenol 15.9 mM
m-cresol 15.9 mM
ionic zinc (as ZnCl2) 19.7 µg/ml (0.3 mM), equals 0.55% (w/w) based on the weight of insulin compound in the formulation
citric acid 22 mM
NaCl 150 mM
Surfactant dodecyl maltoside (0.05 mg/ml)
Water for injection qs
pH adjusted to 7.4
Example E comprises the elected: insulin aspart, dodecyl maltoside, sodium chloride, phosphate buffer, and m-cresol. The Example taught by Gerring contains an additional preservative, phenol. However, the composition taught by Gerring does not contain any zinc binding species which reads on said formulation comprises less than 0.1 mM of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25° (instant claims 3, 6, and 9) and said formulation comprises less than 0.1 mM of a zinc binding species having a logK with respect to zinc ion binding of 10-12.3 at 25° (instant claim 21).
Gerring further teaches in one embodiment, the composition is administered by subcutaneous injection (page 33, lines 10-11).
With regard to the pharmacological properties claimed in instant claims 3, 6, and 9, Gerring does not explicitly teach the properties listed in the claims. Similarly, the cited art does not explicitly teach the stability properties of instant claims 68-70. Claim 3, 6, 9, and 68-70 do not require any other components aside from a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C. Gerring teaches administering a composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C wherein the insulin analogue is present in a concentration that anticipates the claimed concentration (see dependent claims 13 and 14, which depend from claim 3). By broadest reasonable interpretation of the instant claims, a composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C comprising insulin in amounts that anticipate the instantly claimed amounts would possess the instantly claimed pharmacological properties when administered to a subject suffering from diabetes mellitus. Something which is old does not become patentable upon the discovery of a new property. See MPEP 2112 (I).
MPEP 2112(II) states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”).”
In the instant case, the prior art teaches a method of treating diabetes mellitus comprising administering an aqueous liquid composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C. A composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C, meets the structural limitations of the instant claims. Thus, the disclosed composition must inherently possess the functional properties of the claimed composition.
Although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 10, Gerring teaches in one embodiment the insulin compound is insulin aspart (page 16, line 14).
Regarding claims 13 and 14, Gerring teaches insulin aspart at a concentration of 100 U/ml (page 16, lines 14-15).
MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). In the instant case, an amount of 100 U/ml falls within the instant claimed ranges of claims 13 and 14 and thus anticipates the claimed ranges of claims 13 and 14.
Regarding claim 15, Gerring teaches the ionic zinc is present at a concentration of more than 0.05% by weight of zinc based on the weight of insulin compound in the formulation (claim 11).
Regarding claim 16, Gerring teaches the ionic zinc is present at a concentration of more than 0.5% by weight of zinc based on the weight of insulin compound in the formulation (claim 12).
Regarding claim 17, Gerring teaches the ionic zinc is present at a concentration of 0.5-1 % by weight of zinc based on the weight of insulin compound in the formulation (claim 13).
Regarding claim 18, Gerring teaches the zinc binding species is citrate, wherein the source of the citrate is citric acid (claims 15 and 16).
Regarding claim 19, Gerring teaches the zinc binding species having a IogK with respect to zinc ion binding in the range 4.5-12.3 (citric acid) is present at a concentration of 1-50 mM and wherein the molar ratio of ionic zinc to zinc binding species is 1:3 to 1:175 (claims 17 and 18).
Regarding claims 22, 23, 25, and 26, Gerring teaches the alkyl glycoside is dodecyl maltoside (claims 21-23).
Regarding claims 34 and 73, Gerring teaches the non-ionic surfactant is present at a concentration of 1-1000 µg/ml e.g. 5-500 µg/ml, 10-200 µg/ml, 10-100 µg/ml or around 50 µg/ml (claim 24).
Regarding claims 36 and 40, Gerring teaches the formulation further comprising a tonicity modifying agent (claim 26) wherein the tonicity modifying agent is a charged tonicity modifying agent (claim 30), wherein the charged tonicity modifying agent is sodium chloride (claim 31).
Regarding claim 43, Gerring teaches the ionic strength of the formulation excluding the zinc binding species and the insulin compound is <40 mM, e.g. <30 mM, <20 mM or <10 mM, wherein ionic strength is calculated according to the formula la:
PNG
media_image1.png
52
164
media_image1.png
Greyscale
in which cx is molar concentration of ion x (mol L-1), zx is the absolute value of the charge of ion x and the sum covers all ions (n) present in the formulation (claim 33).
Regarding claim 44, Gerring teaches the aqueous formulations of the present invention cover a wide range of osmolarity, including hypotonic, isotonic and hypertonic compositions; more preferably, the osmolarity is about 300 mOsm/L.
Regarding claims 45 and 46, Gerring teaches the pH is in the range 5.5 to 9.0 (claim 35); the pH is in the range 7.0 to 7.5 e.g. 7.4 (claim 36); and the pH is in the range 7.6 to 8.0 e.g. 7.8 (claim 37).
Regarding claim 48, Gerring teaches the formulation comprises a phosphate
buffer e.g. sodium phosphate (claim 38).
Regarding claim 49, Gerring teaches the formulation further comprising a preservative (claim 39) wherein the preservative is the elected m-cresol (claim 40).
Regarding claims 54 and 74, Gerring teaches the formulation does not contain a vasodilator e.g. does not contain treprostinil, nicotinamide, nicotinic acid or a salt thereof (claim 70).
Regarding claim 71, Gerring teaches administration should suitably occur in the window between 15 minutes before eating (i.e. before start of a meal) and 15 minutes after eating (i.e. after end of a meal) (page 33, lines 3-6).
Thus, the teachings of Gerring anticipate the method of claims 3, 6, 9, 10, 13-19, 21-23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74.
Response to Arguments
Applicant argues:
The cited reference does not teach regarding dosage, dosing regimen, or any physical result.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The Examiner notes that claims 13 and 14 depend from claim 3 and thus, further limit the limitations of claim 3. The cited reference teaches amounts of insulin analogue that would anticipate the claimed amounts of claim 13 and 14. Thus, the amounts of claims 13 and 14 are construed to meet the amounts of the claim from which they depend. As set forth above, regarding the physical result, although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
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 3, 6, 9, 10, 13-19, 22, 23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of US Patent No. 12,527,845 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating diabetes mellitus comprising administering an aqueous liquid composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C.
The previously allowed claims are directed to a formulation comprising (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; (iii) a zinc binding species including citric acid; (iv) an alkyl glycoside including the elected dodecyl maltoside; and (v) a charged tonicity modifier, including the elected sodium chloride for use in a method of treating diabetes mellitus. The (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; (iii) a zinc binding species including citric acid; (iv) an alkyl glycoside including the elected dodecyl maltoside of the previously allowed claims are in amounts that would anticipate the instantly claimed amounts and ratios. The formulation of the previously allowed claims further comprises a phosphate buffer and at least one preservative including the elected m-cresol. Thus, the copending claims are directed to a method of treating diabetes mellitus comprising administering compositions that would anticipate the instantly claimed compositions. The previously allowed claims do not explicitly teach the compositions administered result in the pharmacological properties of the instant claims when administered to a subject suffering from diabetes mellitus. Although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Thus, the method and composition of the previously allowed claims would anticipate the instantly claimed method.
Claims 3, 6, 9, 10, 13-19, 22, 23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of US Patent No. 12,357,562 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating diabetes mellitus comprising administering an aqueous liquid composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C.
The copending claims are directed to an injection pen system comprising an aqueous formulation comprising (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; and (iii) an alkyl glycoside including the elected dodecyl maltoside; further comprising a zinc binding species including citric acid wherein the composition is substantially free of EDTA and any other zinc binding species having a logK with respect to zinc ion binding of more than 12.3 at 25 °C and a method for treating diabetes mellitus comprising administering the composition via the injection pen. The (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; (iii) a zinc binding species including citric acid; (iv) an alkyl glycoside including the elected dodecyl maltoside of the previously allowed claims are in amounts that would anticipate the instantly claimed amounts and ratios. The formulation of the copending claims further comprises a phosphate buffer, a tonicity modifying agent including the elected sodium chloride, and a preservative including the elected m-cresol. Thus, the copending claims are directed to a method of treating diabetes mellitus comprising administering compositions that would anticipate the instantly claimed compositions. The previously allowed claims do not explicitly teach the compositions administered result in the pharmacological properties of the instant claims when administered to a subject suffering from diabetes mellitus. Although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Thus, the method and composition of the previously allowed claims would anticipate the instantly claimed method.
Claims 3, 6, 9, 10, 13-19, 36, 43-46, 49, 68-71, 73, and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,278,624 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating diabetes mellitus comprising administering an aqueous liquid composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C.
The previously allowed claims are directed to an aqueous liquid pharmaceutical formulation comprising an insulin analogue including the including the elected, insulin aspart; ionic zinc; citrate as a chelating agent for use in a method of treating diabetes mellitus. The insulin analogue including the elected insulin aspart; ionic zinc; and citrate of the previously allowed claims are in amounts that would anticipate the instantly claimed amounts. The previously allowed claims do not explicitly claim that the composition the formulation is substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C. The previously allowed claims limit the chelator to citrate, thus it is safe to assume the formulations of the previously allowed claims are substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C.
The formulation of the previously allowed claims further comprises at least one preservative including the elected m-cresol. Thus, the copending claims are directed to a method of treating diabetes mellitus comprising administering compositions that would anticipate the instantly claimed compositions. The previously allowed claims do not explicitly teach the compositions administered result in the pharmacological properties of the instant claims when administered to a subject suffering from diabetes mellitus. Although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Thus, the method and composition of the previously allowed claims would anticipate the instantly claimed method.
Claims 3, 6, 9, 10, 13-19, 22, 23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, 10, 11, 15-22, 24-26, 34, 35, 39-42, 44, 45, 47, 50, 51, 69-76, 79-82, 85, 88-91, 93, and 95 of copending Application No. 16/337,730 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating diabetes mellitus comprising administering an aqueous liquid composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C.
The copending claims are directed to a formulation comprising (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; (iii) a zinc binding species including citric acid; (iv) an alkyl glycoside including the elected dodecyl maltoside, wherein the formulation has less than 0.1 mM of any zinc binding species having a logK with respect to zinc ion binding of more than 12.3 at 25 °C; and wherein the formulation is for subcutaneous or intramuscular administration. The instant specification defines substantially free as less than 0.1 mM.
The (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; (iii) a zinc binding species including citric acid; (iv) an alkyl glycoside including the elected dodecyl maltoside of the copending claims are in amounts that would anticipate the instantly claimed amounts and ratios. The ionic strength of the copending composition is calculated using the same formula. The formulation of the copending claims further comprises at least one preservative including the elected m-cresol. Moreover, the specification of the copending application teaches the formulations of the invention may be used in treatment of subjects suffering from diabetes mellitus.
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
Thus, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to administer the composition of the copending claims to treat diabetes mellitus to arrive at a method of treating diabetes mellitus comprising administering compositions that would anticipate the instantly claimed compositions. The copending claims do not explicitly teach the compositions administered result in the pharmacological properties of the instant claims when administered to a subject suffering from diabetes mellitus. Although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3, 6, 9, 10, 13-19, 22, 23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 13, 16-21, 23-31, 34, 36, 38, 39, 42, 43, 45, 48-51, 53, 53, 56-78, 80, and 83 of copending Application No. 17/044,706 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating diabetes mellitus comprising administering an aqueous liquid composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C.
The copending claims are directed to medical infusion pump system comprising an aqueous formulation comprising (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; and (iii) an alkyl glycoside including the elected dodecyl maltoside; (v) citrate; (v) and a tonicity modifying agent including sodium chloride useful in a method for treating diabetes mellitus. The (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; (iii) an alkyl glycoside including the elected dodecyl maltoside; (iv) a zinc binding species including citric acid; and (v) tonicity modifying agent including sodium chloride of the copending claims are in amounts that would anticipate the instantly claimed amounts. The ionic strength of the copending composition is calculated using the same formula. The formulation of the copending claims further comprises at least one preservative including the elected m-cresol.
The copending claims do not explicitly teach the compositions administered result in the pharmacological properties of the instant claims when administered to a subject suffering from diabetes mellitus. Although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3, 6, 9, 10, 13-19, 22, 23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7-9, 13, 16, 20, 23-25, 34-36, 38-43, 45, 46, 48, 51, 52, 58-75, 78, 80, 83, and 84 of copending Application No. 17/044,729 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating diabetes mellitus comprising administering an aqueous liquid composition comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C.
The copending claims are directed to medical infusion pump system comprising an aqueous formulation comprising (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; and (iii) an alkyl glycoside including the elected dodecyl maltoside; and (iv) citrate including citric acid, wherein the composition has less than 0.1 mM of EDTA and any other zinc binding species having a logK with respect to zinc ion binding of more than 12.3 at 25 °C and a method for treating diabetes mellitus comprising administering the composition via the medical infusion pump system. The instant specification defines substantially free as less than 0.1 mM. The (i) an insulin compound including the elected insulin aspart; (ii) ionic zinc; (iii) an alkyl glycoside including the elected dodecyl maltoside; (iv) citrate of the copending claims are in amounts that would anticipate the instantly claimed amounts. The ionic strength of the copending composition is calculated using the same formula. The formulation of the copending claims further comprises at least one preservative including the elected m-cresol.
The copending claims do not explicitly teach the compositions administered result in the pharmacological properties of the instant claims when administered to a subject suffering from diabetes mellitus. Although the reference does not specifically identify that the disclosed wherein the administration of the composition results in the claimed pharmacological properties, the components of the composition are the same. The above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation comprising a fast acting insulin analogue, ionic zinc, and citrate and the formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s request for maintaining the rejection on the grounds of non-statutory obviousness-type double patenting over US Patent Nos. 11,278,624 B2; 12,357,562 B2; and 12,527,845 B2 are noncompliant with the regulations under 37 C.F.R. 1.111. The instant rejection is not a provisional rejection as the claims of US Patent Nos. 11,278,624 B2; 12,357,562 B2; and 12,527,845 B2 have been issued. In the interest of compact prosecution, the examiner has examined the instant application. However, in order for the response to the instant Office Action to be fully responsive and in compliance with the regulations under 37 C.F.R. 1.111, the Applicant should either file a terminal disclosure or traverse the rejection based on US Patent No. Nos. 11,278,624 B2; 12,357,562 B2; and 12,527,845 B2. Because applicant did not distinctly and specifically point out the supposed errors in the instant non-statutory obviousness-type double patent rejection in view of US Patent No. Nos. 11,278,624 B2; 12,357,562 B2; and 12,527,845 B2 and no Terminal Disclaimer has been filed, the rejection is maintained.
With regard to the provisional double patenting rejections, applicant's request for these rejections to be held in abeyance until all other rejections are overcome has been acknowledged. The provisional double patenting rejections over claims 1-3, 6, 7, 10, 11, 15-22, 24-26, 34, 35, 39-42, 44, 45, 47, 50, 51, 69-76, 79-82, 85, 88-91, 93, and 95 of copending Application No. 16/337,730; over claims 1-4, 8, 13, 16-21, 23-31, 34, 36, 38, 39, 42, 43, 45, 48-51, 53, 53, 56-78, 80, and 83 of copending Application No. 17/044,706; and over claims 1, 2, 4, 7-9, 13, 16, 20, 23-25, 34-36, 38-43, 45, 46, 48, 51, 52, 58-75, 78, 80, 83, and 84 of copending Application No. 17/044,729 are maintained and held in abeyance.
Conclusion
Claims 3, 6, 9, 10, 13-19, 21-23, 25, 26, 34, 36, 40, 43-46, 48, 49, 54, 68-71, 73, and 74 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
Prosecution Insights