DETAILED ACTION
Once Applicants resolve the rejections, below, the application should be in condition for allowance.
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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 August 2025, has been entered.
Election/Restrictions
Examiner maintains 103 rejections on record.
Applicant provided compliant species of stabilizing agent: propylene glycol, polyethylene glycol, glycerol.
Examiner extended the Markush search to the full scope of instant claim 1 and made appropriate prior art rejections, below.
Therefore, the restriction requirement is maintained since Group I claims have at least one rejection, below.
Claim 21 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention of Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 26, 2024.
Claims 1-3, 6-14, 16 and 20 are examined in this office action.
Current Status of 17/223,399
This office action is in response to the amendment claims on 08/13/2025.
Original claims 2-3, and 6-14 are original; claims 1, and 16; claim 20 have been previously presented; claim 21 is withdrawn.
Claims 1-3, 6-14, 16 and 20 examined on merit.
Information Disclosure Statement
No IDS was filed as of October 3th 2025.
Priority
The effective filing date is 08/27/2021.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 08/13/2025. Examiner have reviewed these remarks and amendments.
Regarding double patenting rejections over Patent US ‘912 and US ‘305, Applicant filed terminal disclaimer on 8/11/2025; therefore, double patenting rejections are withdrawn.
Regarding 35 USC § 103 rejection of claim 1, Applicant argues:
Mathieson teach away from current invention since succinylcholine chloride is unstable in water. Combining of Mathieson, AKASAPU and Equinox does not provide one of ordinary skill in the art with suggestion or motivation to modify their teachings in a way that would render obvious the amended claim 1, because: Mathieson does not teach a stable composition of succinylcholine chloride in water as the only solvent; and Equinox does not cure the deficiencies in the teaching of Mathieson. AKASAPU does not teach composition of succinylcholine with stabilizing agents selected from the group “propylene glycol, polyethylene glycol, glycerol or mixture thereof”. Proposing such combination would have been hindsight reasoning.
Examiner Response
Examiner does not find applicants argument persuasive.
Mathieson (FR 2716M) uses propylene glycol (applicant elected species of stabilizing agent) to stabilize succinylcholine chloride (only API) in a water-soluble solvent, thus suggesting composition of succinylcholine chloride of the amended claim 1 is stable in physiological condition(water) and does not teach away from the current amended claim 1 as per applicant’s arguments. The deficiency of Mathieson is cure by AKasupa et.al because Akasapu et.al discloses concentration of succinylcholine is in the range of 6mg/mL to 30mg/mL(claim (paragraph [0012] and [0039]) which is within the range of about 5 mg/mL to about 60mg/mL with 0mg/mL of polyethylene glycol(stabilizing agent).
Moreover, applicant did not provide evidence of criticality for the concentration of succinylcholine and stabilizer in remarks of 6/12/2025 (page 8). Applicant stated “The concentration recited serve to demarcate and limit the role of propylene glycol(polyol) as stabilizer of succinylcholine solution (and not as solvent, which generally requires large quantities) together with the limitation of water as the only solvent”. Without proper citation of experiments conducted in the specification, examiner interpret this as attorney’s opinion. Thus 103 rejection is maintained.
Please note the specification discloses composition with 20mg/ml of succinylcholine and 0mg/mL stabilizing agent (see composition K in table 11).
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 1-3, 6-14, 16 and 20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art and (f) Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
Instant claims are drawn to composition of succinyl choline chloride with stabilizing agent consisting of propylene glycol, polyethylene glycol, glycol, glycerol and mixtures thereof. The specification describes composition comprising of succinylcholine chloride and propylene glycol and/or polyethylene glycol (see table 5- 11) in water. Specification do not disclose composition of various glycol or glycerol. Specification also do not disclose composition comprising of succinylcholine chloride with mixture of propylene glycol, polyethylene glycol, glycol, glycerol in water. Therefore, examiner is not able to determine if the applicant is in possession of the composition comprising of succinylcholine chloride with mixture of propylene glycol, polyethylene glycol, glycol, glycerol or with other glycols and glycerol. Thus claim 1 is rejected as lacking written description.
Claims 2-3, 6-14, 16 and 20 are rejected for depending on rejected claim 1 because they refer back to claim 1 but does not remedy the bases for the rejection of claim 1.
Applicant can overcome lack of written description by deleting glycol and glycerol from claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-14, 16 and 20 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 recites the limitation “one or more stabilizing agents selected from the group consisting of propylene glycol, polyethylene glycol, glycerol, and mixtures thereof present at a concentration of less than about 300 mg/mL” which is contradictory because the limitation “one or more stabilizing agent” interpreted as, there must be at least one of the stabilizer in the composition, but the limitation “less than 300mg/mL” is interpreted as the concentration of stabilizing agent can me 0ml/mL, since the limitation “less then 300mg/mL” does not set lower bound for the concentration of stabilizing agent. The limitation “one or more stabilizing agent” and the limitation “less than 300mg/mL” in claim 1 fails to particularly point out and distinctly claim the subject matter of claim 1, thus renders metes and bounds of claim 1 indefinite. Thus claim 1 is rejected for being indefinite.
Claims 2-3 6-14, 16 and 20 are also rejected as indefinite because they refer back to claim 1 but do not remedy the bases for the rejection of claim 1.
Claim 16 recites “composition of claim 1 wherein the concentration is from about 20mg/mL to about 300mg/mL” without referencing to which component of the composition from claim 1 the applicant is referring. Claim 16 fails to particularly point out and distinctly claim the subject matter of the claim 1, therefore renders metes and bound of claim 16 undefined since examiner does not know what component of claim 1 “the composition” of claim 16 is referencing. Are the concentration range of claim 16 referring to the succinylcholine chloride of claim 1 or the entire pharmaceutical composition of claim 1? Therefore, claim 16 is rejected as indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 recites “composition of claim wherein the concentration is from about 20mg/mL to about 300mg/mL” without referencing to which component of the composition in claim 1. Therefore claim 16 does not further limit the subject matter of the claim 1 and claim 16 is rejected under 35 USC 112(d).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-10, 13-14, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AKASAPU P S et. al. (WO2019177725A1, Publication date 2019-09-19)
AKASAPU P S et. al. teaches prefilled syringe (claim 3) and kit with (injection device) (claim 13-14) with pharmaceutical composition comprising succinylcholine chloride, and water(only solvent), wherein the succinylcholine chloride composition (wherein succinylcholine chloride is only active ingredient) has no preservative(stabilizing agent) (examiner is interpreting this as 0mg/mL, which is “less than about 300 mg/mL” of “stabilizing agents”) (paragraph [0010]). The succinylcholine chloride composition has a pH of about 3.0 to about 4.5 anticipating Claim 10 (paragraph [0010]). Akasapu et.al disclose concentration of succinylcholine is in the range of 6mg/mL to 30mg/mL(claim (paragraph [0012] and [0039]) which is within the range of about 5 mg/mL to about 60mg/mL thus anticipating claim 1 and 16. Akasupu et.al further discloses the composition of succinyl choline chloride solution is stable for 30 days (see table 2 ) in aqueous solution, thus anticipating claim 1. The AKASAPU reference is silent as to “tonicity contributing agent” hence it is “free of tonicity contributing agent” and hence anticipates instant claim 2.
The limitation “wherein the composition is in the form of an aqueous solution suitable for parenteral administration” is interpreted as an inherent property/function. This property/function is inherently taught/anticipated by AKASAPU. See MPEP 2112.01(I) and (II).
Similarly the property: “stable at room temperature for at least 30 days” is deemed inherent. See MPEP 2112.01(I) and (II).
AKASAPU P S et. al. teaches impurities in the composition with 20mg/mL (anticipating claim 20) of succinyl choline chloride is between 0.1-0.2% after storage at 25°C at 60%RH for 3 months (90 days) as determined by HPLC(table 2 paragraph [0045]), which is below 6% (claim 6), 0.5% (claim 7), 5% (claim 8) and 3%(claim 9) thus anticipating claim 6-9.
Please note Akusapu is silent on what type of % impurities therefore examiner interpret this as (w/w) of claim 6-9.
Claims 1-3, 6-11, 13-14, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AKASAPU P S et. al. (WO2019177725A1, Publication date 2019-09-19) with evidentiary reference of Equinox (Plas-Tech Engineering, Published October 14, 2017, https://www.plastechengineering.com/glass-replacement, retrieved March 21, 2024).
Akusapu et.al. anticipates claims 1-3, 6-10, 13-14, 16 and 20. Equinox teaches cyclo-olefin copolymer (COC) (Applicants’ elected species for claim 11) “plastic syringes for the pharmaceutical and medical industry” (page 3). In particular COC medical syringe extends the shelf life of pharmaceutical solutions (end of page 3) anticipating claim 11. Therefore, Equinox relied on beneficial teaching of Akusapu et.al. to anticipate claims1-3, 6-11, 13-14, 16 and 20.
Claims 1-3, 6-10, 12-14, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AKASAPU P S et. al. (WO2019177725A1, Publication date 2019-09-19) with evidentiary reference of Mathieson (FR2716M)
Akusapu et.al. anticipates claims 1-3, 6-10, 13-14, 16 and 20. Mathieson in Example 1 teaches the solution of the composition is sterilized by filtration through a bacteria-retaining filter such as porous porcelain (claim 12) Therefore, Mathieson relied on beneficial teaching of Akusapu et.al. to anticipate claims 1-3, 6-10, 12-14, 16 and 20.
Claim Rejections - 35 USC § 103(Maintained with modification)
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6-14, 16, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
AKASAPU P S et. al. (WO2019177725A1, Publication date 2019-09-19)
In view of WO2019177725A1
Mathieson (FR2716M)
In further view of
Equinox (Plas-Tech Engineering, Published October 14, 2017, https://www.plastechengineering.com/glass-replacement, retrieved March 21, 2024).
Determining the scope and contents of the prior art.
AKASAPU P S et. al teaches claims 1-3, 6-10, 13-14, 16, and 20 (see 102 rejections above)
Mathieson in paragraph 35 teaches in Example 1: 100mg of succinylcholine chloride (interpreted as “therapeutically effective amount of succinylcholine chloride”) (claims 1) is dissolved in enough propylene glycol, which is a type of “aliphatic polyols” of claim 1 (applicants elected species of stabilizing agent, claims 1-2) to give 1 cm3 of final solution with a pH of 5.8 and the pH can be adjusted with hydrochloric acid to 3.4 thus anticipates instant claim 10.
MATHIESON teaches the solution of hydrochloric acid contain water (applicant’s elected species of “pharmaceutically acceptable solvents” of claim 1). Mathieson in example 1 do not mention tonicity or the presence of sodium chloride thus anticipates claims 2. Furthermore, since MATHIESON teaches the pharmaceutical formulation of succinylcholine chloride, stabilizing agent, and water, as per, above, the property: “stable at room temperature for at least 30 days” is deemed inherent. See MPEP 2112.01(I) and (II).
Example 1 also teaches the solution of the composition is sterilized by filtration through a bacteria-retaining filter such as porous porcelain (claim 12) and then put into vials (claim 3). The solution is stable indefinitely when stored at room temperature (paragraph 35). Thus, teaching all the embodiments of the independent claim 1 and its dependent claims 3,10, and 12.
Mathieson specifically teaches in paragraph 17, the solutions of non-toxic salt of choline esters in organic solvents are miscible with water, acceptable by parenteral route (reads on an injection device(syringe) having a needle claims 3 and 13-14). This teaches independent claims 3 and 13-14. Mathieson further teaches “injectable pharmaceutical composition” of claims 1, 4 and 20 (20 mg of succinylcholine chloride used in Example 6 para [0041]).
Equinox teaches cyclo-olefin copolymer (COC) (Applicants’ elected species for claim 11) “plastic syringes for the pharmaceutical and medical industry” (page 3). In particular COC medical syringe extends the shelf life of pharmaceutical solutions (end of page 3) teaching instant claim 11.
Ascertaining the differences between the prior art and the claims at issue.
Although AKASAPU P S et. al. teaches prefilled syringe and kit with composition of succinyl choline chloride in only water . However AKASAPU P S et. al. does not teach sterilization or a prefill syringe made of cyclo-olefin polymer with composition of claim 1.
Although MATHIESON teaches Claims 1-3,6-10, 12-14, and 20, see above, MATHIESON fails to teach the succinyl choline composition only in water. Mathieson further fails to teach concentration of the aliphatic polyols of claims 15-16 or a syringe made of cyclo-olefin-polymer to prefill with composition of claim 1.
Equinox teaches cyclo-olefin copolymer (COC) “plastic syringes for the pharmaceutical and medical industry” (page 3). In particular COC medical syringe extends the shelf life of pharmaceutical solutions (end of page 3) teaching instant claim 11. Equinox does not teach the use of syringe made of cylo-olefin-copolymer for composition of claim 1.
Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill in the art is represented by an artisan who has sufficient background in developing injectable anesthetic composition to optimize the shelf life of the pharmaceuticals.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The instant claims 1-3, 6-14, 16, and 20 are prima facie obvious in light of the combination of the references Mathieson, Akasupa and Equinox.
The artisan would be motivated to use composition of claim 1, described in Mathieson (Example 1, paragraph 35) and AKASAPU P S et. al. (paragraph [0010] in a pre-filled syringe made of COC to increase the shelf life (Equinox, end of page 3) of the composition, thus teaching claim 11. The artisan would be motivated to combine the teaching of Mathieson (Example 1, paragraph 35) and Akasapu et. al (paragraph [0010]) with the teaching of Equinox (end of page 3) to develop a kit contain succinyl choline chloride in water with stabilizing agent thus teaching claims 13-14.
Conclusion
No claims are allowable as written.
Applicant can overcome 102 rejection(s) by giving a lower range of concentration for the stabilizing agent that does not permit 0 mg/mL.
Please note the specification discloses composition with 20mg/ml of succinylcholine and 0mg/mL stabilizing agent (see composition K in table 11).
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625