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 .
Election/Restrictions
Applicant’s election without traverse of Group I (i.e., claims 1-4 drawn to a lyophilized sovateltide-based injectable formulation) in the reply filed on May 19, 2026, is acknowledged. Additionally, Applicant’s election without traverse of Species A (i.e., a single and specific active pharmaceutical ingredient as sovateltide); and Species B (i.e., a single and specific combination of excipients as trisodium citrate dihydrate and mannitol) in the reply filed on May 19, 2026, is acknowledged.
Status of Claims
Claims 1-10 were originally filed on September 29, 2023.
Claims 1-10 are currently pending and claims 1-4 are under consideration as claims 5-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 19, 2026.
Priority
The present application is a continuation-in-part of US. Application No. 18/343,087, filed on June 28, 2023.
However, please note that the scope of instant claims 1-4 have an effective priority date of September 29, 2023 (i.e., the filing date of the instant application) because the scope of independent claim 1 encompasses subject matter that is not supported by the aforementioned priority document. MPEP 2163.05 states, to comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. 1, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, or 365(c), each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure. It is noted that the instant formulation, a lyophilized sovateltide-based formulation comprising components (i), (ii) and (iii) is not expressly, implicitly, or inherently supported in the priority documents.
More specifically, the subject matter not supported by the priority documents pertains to, at a minimum, the formulation being a lyophilized formulation containing at least two soluble excipients, and instant component (iii), i.e., water for injection in the range of 1-2% w/w. The priority document only refers to one specific lyophilized formulation, i.e., a specific combination of mannitol and sovateltide or sovateltide and citicoline (See ‘087, [0036]). Moreover, ‘087 does not expressly or implicitly teach a lyophilized formulation that contains water in the range of 1-2% w/w or reconstituted in water in an amount ranging from 1-2% w/w. Therefore, the effective filing date of the instant application is September 29, 2023.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on September 29, 2023; May 6, 2024; December 29, 2025; and March 19, 2026, are being considered by the examiner.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
For claim 1, with respect to “lyophilized” formulation, it is noted that the instant specification defines a “lyophilized” powder or cake or preparation as referring to any solid substance that has undergone the process of lyophilization or freeze-drying of aqueous solution (See instant, [0024]). As such, the instant formulation is a solid substance that has undergone the process of lyophilization of an aqueous solution comprising the three instant components.
With respect to a “sovateltide-based” formulation, it is noted that the instant specification does not define what is meant by a “sovateltide-based” formulation. Pursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1).
It is further noted that component (i) as recited in instant claim 1, only refers to an active pharmaceutical ingredient, and thus, encompasses any pharmaceutical ingredient. However, the instant specification and Examples 1-15 only describe sovateltide as the active pharmaceutical ingredient (See instant, Examples 1-15). Thus, the instant specification supports a sovateltide-based formulation that contains sovateltide as the active pharmaceutical ingredient. But as further articulated in the 112(b) rejection below, it is unclear what a sovateltide-based formulation is to contain other than sovateltide. As indicated below, the Examiner is interpreting the scope of claim 1 as it relates to a sovateltide-based formulation as one that requires sovateltide as a pharmaceutical ingredient, but can also contain an additional active pharmaceutical ingredient where either ingredient is present in an amount ranging from 0.01-0.02% w/w. In light of this interpretation, the written description requirement is met.
Claim Objections
Claim 3 is objected to because of the following informalities: claim 3 recites, “mannitol,….sodium chloride, hydroxypropyl beta cyclodextrin.” It is respectfully requested that claim 3 recites, “mannitol,….sodium chloride, and hydroxypropyl beta cyclodextrin” in order to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is directed to a lyophilized sovateltide-based injectable formulation comprising (i) an active pharmaceutical ingredient in the range of 0.01-0.02% w/w, (ii) at least two soluble excipients in the range of 20-80% w/w, and (iii) water for injection in the range of 1-2% w/w. Claim 1 encompasses multiple separate ambiguities.
First, it is unclear what constitutes a sovateltide-based formulation, especially given that component (i) encompasses any active pharmaceutical ingredient and dependent claim 2 limits the pharmaceutical ingredient to sovateltide. As discussed in the “Claim Interpretation” section supra, the instant specification provides no other examples of sovateltide-based products. Nor does the instant specification define what is meant by a sovateltide-based formulation. Furthermore, a sovatelide-based formulation comprising any active pharmaceutical ingredient encompasses multiple interpretations; for example, where the formulation contains a sovateltide fragment, analog, and/or derivative (i.e., a product that is modified relative to sovateltide), or where the formulation contains sovateltide in combination with another active pharmaceutical ingredient. As such, it is unclear what constitutes a sovateltide-based formulation, especially given the lack of nexus between the preamble and component (i).
Second, component (ii) is directed to where there are two soluble excipients in a range of 20-80% w/w. However, component (ii) encompasses multiple interpretations. The first interpretation encompasses where both excipients are present in a total amount ranging from 20-80% w/w. The second interpretation encompasses where each excipient is present in an amount ranging from 20-80% w/w. It is noted that the formulation of Example 1 utilizes 0.015% w/w of sovateltide, ~76% mannitol, and ~ 23.8% trisodium citrate (See instant, Example 1). As such, the instant specification supports the second interpretation. As such, it is unclear which interpretation applies to claim 1.
Third, component (iii) is directed to where the formulation contains water for injection in the range of 1-2% w/w. Given that the formulation is a lyophilized formulation, i.e., a solid substance that has undergone the process of lyophilization of an aqueous solution as discussed in the “Claim Interpretation” section supra, it is unclear if the water of component (iii) is included for reconstituting the lyophilized formulation in water in an amount ranging from 1-2% w/w, and thus, not a structural component of the lyophilized formulation, or if the water is a component of the lyophilized formulation since the formulation was lyophilized from an aqueous solution. It is noted that the instant specification refers to water in each of formulation examples 1-15 for reconstitution purposes, and thus, is not a structural component of the lyophilized formulation (See instant, Examples 1-15). Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to (1) what constitutes a sovateltide-based formulation, (2) whether the at least two soluble excipients are each present in an amount ranging from 20-80% w/w or as a total excipient w/w percentage, and (3) whether the water of component (iii) is simply included as part of the intended use of the lyophilized formulation, i.e., reconstituted in water in a range of 1-2% w/w for injection, or if the water is a freeze-dried component in the lyophilized formulation.
Please note that the Examiner is interpretating the scope of claim 1 such that (1) a sovateltide-based formulation must require sovateltide as a pharmaceutical ingredient, but can also contain an additional active pharmaceutical ingredient where either ingredient is present in an amount ranging from 0.01-0.02% w/w, (2) the at least two soluble excipients are present individually in a range of 20-80% w/w as long as the total w/w of the formulation does not exceed 100% w/w, and (3) where the water is used to reconstitute the lyophilized formulation for injection in an amount ranging from 1-2% w/w in order to advance prosecution.
Also please note that claims 2-4 are rejected by virtue of their dependency.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Pursuant to MPEP 2173.05(h), [a] Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. Here, claim 3 is directed to where the soluble excipient includes, but not limited to mannitol,….hydroxypropyl beta cyclodextrin. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention because it is unclear what other alternatives are intended to be encompassed by each claim.
Please note that the Examiner is interpreting the scope of claim 3 such that the excipient is selected from the group consisting of the recited species in order to advance prosecution.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 4 is directed to where the soluble excipients are ideally mannitol… The word "ideally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Please note that the Examiner is interpreting the scope of claim 4 such that it is directed to where the soluble excipients are mannitol as a freeze-drying filler and trisodium citrate dihydrate as a buffering agent in order to advance prosecution.
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 pre-AIA 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/075379 A1 published on June 26, 2008 (cited in the IDS received on 5/6/24), alone or as evidenced by PubChem, Sodium Citrate Dihydrate, PubChem CID 71474, 66 pages (2025).
For claims 1-4, ‘379 claims a stable formulation for enhanced delivery of diagnostic agents to solid tumor tissues in safe dosage form comprising an active agent and stabilizers, where (a) the active agent is a synthetic peptide endothelin B receptor agonist present in a concentration range of 0.01 mg to 0.05 mg/vial of the formulation, and (b) the stabilizers are mannitol in concentration range of 25-75 mg/vial of the formulation and sodium citrate (dihydrate) (i.e., trisodium citrate dihydrate as evidenced by the PubChem reference at pg. 1, synonym section) in concentration range of 10-45 mg/vial (40-60% of mannitol concentration) of the formulation where the formulation is to be reconstituted with water for injection before administration (See ‘379, amended claim 1; pg. 5, 6th paragraph; pg. 6, 3rd paragraph). The endothelin B receptor agonist is a peptide such as IRL-1620 (i.e., sovateltide) (See ‘379, amended claim 3; pg. 5, 2nd paragraph). Although not expressly claimed, since ‘379 claims that the stable formulation is reconstituted with water for injection before administration, it must follow that the stable formulation is in a form that can be reconstituted. Plus, ‘379 teaches that the formulation is a lyophilized formulation stored in a glass vial (See ‘379, pg. 5, last paragraph). Therefore, ‘379 teaches a lyophilized sovateltide-based formulation comprising (i) sovateltide as an active pharmaceutical ingredient as recited in instant claims 1-2, (ii) mannitol and trisodium citrate dihydrate as two soluble excipients as recited in instant claims 1 and 3-4, and (iii) water for injection as recited in instant claim 1.
Regarding where the formulation is injectable, as discussed supra, ‘379 claims where the formulation is to be reconstituted with water for injection before administration. Thus, ‘379 satisfies the claim limitation with respect to where the formulation is injectable as recited in instant claim 1.
However, even if ‘379 did not expressly teach that the formulation is injectable, pursuant under MPEP 2111.02(II):
statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. (emphasis added).
As such, a formulation in the preamble is intended to be administered via injection. Thus, the claimed formulation being an injectable formulation is the intended use of the formulation. Although ‘379 teaches reconstituting the sovateltide formulation with water for injection, the formulation would then be in a form that renders the ‘379 formulation being capable of performing the claimed intended use, i.e., being an injectable formuation. Thus, the teachings of ‘379 satisfy the claim limitation with respect to where the formulation is an injectable formulation as recited in instant claim 1.
Regarding where the sovateltide is present in an amount ranging from 0.01-0.02% w/w, as discussed supra, ‘379 claims where sovateltide is present in a concentration range of 0.01 mg to 0.05 mg/vial of the formulation. Calculating the total weight of the ‘379 formulation equates to 35.01 mg (i.e., 0.01 mg + 25 mg + 10 mg) to 120.05 mg (i.e., 0.05 mg + 75 mg + 45 mg). As such, the w/w of sovateltide in the formulation includes an amount ranging from 0.0286% to 0.0417% w/w of the formulation (i.e., (0.01/35.01 x 100 = 0.0286) and (0.05/120.05 x 100 = 0.0417)), and an amount ranging from 0.0083% to 0.14% w/w of the formulation (i.e., (0.05/35.05 x 100 = 0.14) and (0.01/120.01 x 100 = 0.0083)). Thus, the amount of sovateltide is close to the claimed w/w % (i.e., 0.0286%), overlaps with the instant w/w % (i.e., 0.0083% to 0.14% w/w), and/or is optimized in light of the teachings of ‘379.
With respect to when the w/w % is close to the claimed w/w %, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metal Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held a proper rejection of a claim directed toward an alloy of having "0.8% nickel, 0.3% molybdenum, 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.) Therefore, the claimed amount of sovateltide would have been suggested to one skilled in the art given that the claimed amount (i.e., 0.01-0.02% w/w) is close to the taught amount (i.e., 0.0286% w/w).
With respect to when the w/w % overlaps with the claimed w/w %, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed w/w % range of sovateltide would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 0.01-0.02% w/w) overlaps with the prior art w/w % range of sovaleltide (i.e., 0.0083% to 0.14% w/w).
Additionally and/or alternatively, the w/w % of sovateltide in the formulation is clearly a result specific parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal w/w% of sovateltide in the formulation needed to achieve the desired results. Thus, an ordinary skilled artisan would have been motivated to adjust the w/w % of sovateltide in the formulation in light of the teachings of ‘379, for formulating a stable lyophilized sovateltide formulation, because an ordinary skilled artisan would have been able to utilize the teachings of ‘379 to obtain various w/w % parameters with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the w/w % of sovateltide in the formulation would have been obvious at the time of applicant's invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
Regarding where the excipients are present in an amount ranging from 20-80% w/w, as discussed supra, ‘379 claims where mannitol is present in a concentration range of 25-75 mg/vial of the formulation and sodium citrate (dihydrate) (i.e., trisodium citrate dihydrate as evidenced by the PubChem reference at pg. 1, synonym section) is present in a concentration range of 10-45 mg/vial (40-60% of mannitol concentration) of the formulation. Calculating the total weight of the ‘379 formulation equates to 35.01 mg (i.e., 0.01 mg + 25 mg + 10 mg) to 120.05 mg (i.e., 0.05 mg + 75 mg + 45 mg). For mannitol, the w/w % includes an amount ranging from 62% w/w to 71% w/w (i.e., (25/35.01 x 100 = ~71) and (75/120.05 x 100 = ~62)). For sodium citrate dihydrate, the w/w % includes an amount ranging from 28.6% w/w to 37.4% w/w (i.e., (10/35.01 x 100 = ~28.6) and (45/120.05 x 100 = ~37.4). However, it is noted that ‘379 requires sodium citrate dihydrate to be 40-60% the amount of mannitol. For example, if mannitol is 62% w/w, then the amount of sodium citrate dihydrate would range from 24.8% w/w (i.e., 40% of 62% mannitol) to 37.2% w/w (i.e., 60% of 62% mannitol) whereby the amount would be limited to 28.6% w/w to 37.2% w/w given that is the sodium citrate dihydrate amount ranges from 28.6% w/w to 37.4% w/w. Thus, the amount of mannitol and trisodium citrate dihydrate each overlap with the instant w/w % (i.e., 20-80% w/w), and/or is optimized in light of the teachings of ‘379.
With respect to when the w/w % overlaps with the claimed w/w %, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed w/w % range of mannitol would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 20-80% w/w) overlaps with the prior art w/w % range of mannitol (i.e., 62% w/w to 71% w/w). Moreover, the claimed w/w % range of trisodium citrate dihydrate would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 20-80% w/w) overlaps with the prior art w/w % range of trisodium citrate dihydrate (i.e., 28.6% w/w to 37.2% w/w).
Additionally and/or alternatively, the w/w % of mannitol and trisodium citrate dihydrate in the formulation are clearly result specific parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal w/w% of mannitol and trisodium citrate dihydrate in the formulation needed to achieve the desired results. Thus, an ordinary skilled artisan would have been motivated to adjust the w/w % of mannitol and trisodium citrate dihydrate in the formulation in light of the teachings of ‘379, for formulating a stable lyophilized sovateltide formulation, because an ordinary skilled artisan would have been able to utilize the teachings of ‘379 to obtain various w/w % parameters with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the w/w % of mannitol and trisodium citrate dihydrate in the formulation would have been obvious at the time of applicant's invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
Regarding water for injection in the range of 1-2% w/w, as discussed supra, ‘379 teaches adding water to reconstitute the lyophilized sovateltide formulation for injection before administration. Thus, the teachings of ‘379 satisfy the claim limitation with respect to water for injection as recited in instant claim 1. However, ‘379 does not expressly teach the w/w % of water needed to reconstitute the lyophilized sovateltide formulation for injection. As discussed supra in the 112(b) rejection, the Examiner is interpreting that the water is added for reconstitution purpose in an amount ranging from 1-2% w/w. As such, the claimed w/w % of water is also a limitation associated with the intended use of the claimed formulation, and thus, is not a structural limitation of the claimed formulation. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02. Moreover, “[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is necessarily present in the prior art does not necessarily make the claim patentable. As such, the inclusion of water in an amount ranging from 1-2% w/w corresponds to an intended use of the claimed formulation for administration via injection via reconstitution. A recitation of an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Accordingly, since ‘379 teaches reconstituting a lyophilized sovateltide formulation with water for administration via injection, the intended use of the formulation is also met.
For claim 4, with respect to where mannitol is a freeze-drying filler and trisodium citrate dihydrate is a buffering agent, as discussed supra, ‘379 claims mannitol and trisodium citrate dihydrate as stabilizers in a lyophilized sovateltide formulation. ‘379 does not expressly teach that mannitol is a freeze-drying filler and trisodium citrate dihydrate is a buffering agent. However, since ‘379 expressly teaches mannitol (i.e., a species of freeze-drying filler) and trisodium citrate dihydrate (i.e., species of buffering agent), it would necessarily follow that the species read on the broader genus of excipient categories.
Additionally, the functional properties (i.e., being a freeze-drying filler and as a buffering agent) of mannitol and trisodium citrate dihydrate as claimed and the known mannitol and trisodium citrate dihydrate would necessarily read upon the same. The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of new functional properties (i.e., being a freeze-drying filler and as a buffering agent) which would necessarily read upon the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 4333 (CCPA 1977).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 54-74 of copending Application No. 19/433,400 (US 2026/0130858 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘400 claims:
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(See ‘400, claims 54-56, 61-62, and 68-69). As such, the ‘400 lyophilized pharmaceutical composition constitutes the instant lyophilized sovateltide-based formulation comprising sovateltide as an active pharmaceutical ingredient in present in an amount of 0.01-0.02 w/w and at least two soluble excipients each in an amount ranging from 20-80% w/w where the excipients are mannitol and trisodium citrate dihydrate as recited in instant claims 1-4. Plus, ‘400’s reconstituted liquid composition where the liquid can be water present in an amount sufficient to reconstitute the lyophilized pharmaceutical composition. As such, the ‘400 claimed invention encompasses where the water is added in an amount sufficient to reconstitute the lyophilized pharmaceutical composition as recited in instant claim 1. Although ‘400 does not expressly claim where the composition is injectable or water is used in order to reconstitute the composition for injection, and does not expressly claim where the amount sufficient to reconstitute the lyophilized composition is 1-2% w/w, these limitations correspond to intended use limitations that do not impart a structural limitation to the instant formulation for the reasons set forth in the 103(a) rejection supra. Thus, the ‘400 claimed invention anticipates the instantly claimed invention. Therefore, the ‘400 claimed invention is not patentably distinct from the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
Prosecution Insights