DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of group I, species A, and subspecies H in the reply filed on 8/7/2026 is acknowledged. The traversal is on the ground(s) that groups/species pose no additional search or examination burden. This is not found persuasive since as detailed in the requirement for restriction mailed 6/8/2026, this application is a national stage application which is evaluated for unity of invention rather than independence/distinctness and search/examination burden. Groups I-III lack unity of invention with each other because the shared technical feature is not a special technical feature as it does not make a contribution over the prior art as detailed in the requirement for restriction mailed 6/8/2026. Therefore, as the inventions and species lack unity of invention, the requirement for restriction is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-14, 16-24 and 30-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species/subspecies, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/7/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is less than 50 words. Examiner suggests adding more detail to the abstract regarding the instant invention in order to provide a concise statement of the technical disclosure of the patent and what is new in the art to which the invention pertains. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 3 objected to because of the following informalities:
Line 1 recites “comprises chronic migraine”. Examiner suggests replacing “comprises chronic migraine” in line 1 of claim 3 with “comprises a chronic migraine treatment” to put the claim in clearer grammatical form. See also 112 rejection of claim 3 below.
Claim 58 objected to because of the following informalities:
Line 1 recites “said vessel bottom interior”. Claim 58 depends on claim 57. Claim 57 recites “said vessel comprises a bottom interior”. Examiner suggests replacing “said vessel bottom interior” in line 1 of claim 58 with “said bottom interior of said vessel” to put the claim in clearer form and more clearly refer to the bottom interior of the vessel introduced in claim 57.
Claim 59 objected to because of the following informalities:
Line 1 recites “said vessel bottom interior”. Claim 59 depends on claim 57. Claim 57 recites “said vessel comprises a bottom interior”. Examiner suggests replacing “said vessel bottom interior” in line 1 of claim 59 with “said bottom interior of said vessel” to put the claim in clearer form and more clearly refer to the bottom interior of the vessel introduced in claim 57.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 15, 25-29, and 57-59 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.
In regard to claim 1,
Line 2 recites “the amount of neurotoxin”. There is insufficient antecedent basis for the limitation in this claim. Line 1 introduces “neurotoxin formulations”. It is unclear if the amount of neurotoxin refers to an amount of a neurotoxin in the neurotoxin formulations or to an amount of a neurotoxin or to an amount of neurotoxin formulations. For examination purposes Examiner construes “the amount of neurotoxin” to be “an amount of a neurotoxin”. Examiner suggests replacing “the amount of neurotoxin” in line 2 of claim 1 with “an amount of a neurotoxin”.
Examiner notes claims 2-8, 15, 25-29, and 57-59 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 3,
Line 1 recites “said migraine”. There is insufficient antecedent basis for the limitation in this claim. Claim 3 depends on claim 2. Claim 2 introduces a migraine treatment. It is unclear if said migraine is intended to refer to the migraine treatment or to a migraine. For examination purposes Examiner construes “said migraine” to be “said migraine treatment”. Examiner suggests replacing “said migraine” in line 1 of claim 3 with “said migraine treatment”. It is noted if “said migraine” is replaced with “said migraine treatment”, “chronic migraine” should also be replaced with “a chronic migraine treatment”.
Examiner notes claims 4-8 and 15 are similarly rejected by virtue of their dependency on claim 3.
In regard to claim 5,
Line 1 recites “said neurotoxin”. Claim 5 depends on claim 4, 3, 2, and 1. Claim 4 introduces a neurotoxin and claim 1 also recites a neurotoxin. It is unclear which neurotoxin claim 5 is referring to. For examination purposes Examiner construes the neurotoxin in claim 1 and 4 to be the same neurotoxin. Examiner suggests replacing “of neurotoxin” in line 1-2 of claim 4 with “of the neurotoxin”.
Examiner notes claims 6-8 and 15 are similarly rejected by virtue of their dependency on claim 5.
In regard to claim 26,
Line 1 recites “The stopper of claim 25”. Claim 25 is drawn to a vessel, not a stopper. It is unclear if claim 26 is intending to further limit the vessel or introduce a stopper. For examination purposes Examiner construes “The stopper of claim 25” to be “The vessel of claim 25”. Examiner suggest replacing “The stopper of claim 25” in line 1 of claim 26 with “The vessel of claim 25”.
Examiner notes claim 27 is similarly rejected by virtue of its dependency on claim 26.
In regard to claim 27,
Line 1 recites “the color-coded stopper of claim 26”. Claim 27 depends on claim 26, 25, and 1. Claim 1 and 25 are drawn to a vessel, not a color-coded stopper. It is unclear if claim 27 is intending to further limit the vessel or introduce a color-coded stopper. For examination purposes Examiner construes “The color-coded stopper of claim 26” to be “The vessel of claim 26”. Examiner suggest replacing “The color-coded stopper of claim 26” in line 1 of claim 27 with “The vessel of claim 26”.
Line 1 recites “said color”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if “said color” refers to “a color of the color-coded stopper”. For examination purposes Examiner construes “said color” to be “a color of the color-coded stopper”. Examiner suggests replacing “said color” in line 1 of claim 27 “a color of the color-coded stopper”.
In regard to claim 29,
Line 1 recites “the color-coded vessel of claim 28”. Claim 29 depends on claim 28 and 1. Claims 1 and 28 are drawn to a vessel, not a color-coded vessel. It is unclear if claim 29 is intending to further limit the vessel or introduce a color-coded vessel. For examination purposes Examiner construes “The color-coded vessel of claim 28” to be “The vessel of claim 28”. Examiner suggest replacing “The color-coded vessel of claim 28” in line 1 of claim 29 with “The vessel of claim 28”.
Line 1 recites “said color”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if “said color” refers to “a color of the color-coded vessel”. For examination purposes Examiner construes “said color” to be “a color of the color-coded vessel”. Examiner suggests replacing “said color” in line 1 of claim 29 “a color of the color-coded vessel”.
In regard to claim 57,
Line 2 recites “the bottom exterior”. There is insufficient antecedent basis for the limitation in this claim. It is also unclear which structure the bottom exterior is of. For examination purposes Examiner construes “the bottom exterior” to be “a bottom exterior”. Examiner suggests deleting “that is not parallel to the bottom exterior” as support does not appear to be present to further define the bottom exterior as the specification is completely silent regarding what structure the bottom exterior is of.
Examiner notes claims 58-59 are similarly rejected by virtue of their dependency on claim 57.
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)(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 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubio (U.S. PG publication 20200384090).
In regard to claim 1,
Rubio discloses a vessel (syringe; paragraph [0134] and [0178]) for neurotoxin formulations (Examiner notes “for neurotoxin formulations” is a functional limitation. Neurotoxin formulations are fully capable of being within the vessel as supported by paragraph [0134] and [0178]), wherein said vessel contains between 100% and 110% of the amount of neurotoxin (paragraph [0153], [0134], [0178]) intended to be administered to a patient in a single fixed-site fixed-dose treatment session (Examiner notes “intended to be administered to a patient in a single fixed-site fixed-dose treatment session” is a functional limitation. The amount of neurotoxin is not positively required to be administered to a patient in a single fixed-site fixed-dose treatment session. The amount of neurotoxin in the vessel is fully capable of being administered to a patient in a single fixed-site fixed-dose treatment session due to the structure of the vessel and as supported by paragraph [0153]).
In regard to claim 2,
Rubio discloses the vessel of claim 1, wherein said treatment session comprises a migraine treatment (paragraph [0025] and [0137]; As noted above, “intended to be administered to a patient in a single fixed-site fixed-dose treatment session” is functional limitation. The treatment session is not positively required).
Claims 1 and 57-59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar (U.S. PG publication 20120088714).
In regard to claim 1,
Kumar discloses a vessel (figure 3A, item 300) for neurotoxin formulations (Examiner notes “for neurotoxin formulations” is a functional limitation. Neurotoxin formulations are fully capable of being within the vessel as supported by paragraph [0002] and [0020]-[0022]), wherein said vessel contains between 100% and 110% of the amount of neurotoxin (paragraph [0002], [0020]-[0022], [0037]-[0038] and [0041]) intended to be administered to a patient in a single fixed-site fixed-dose treatment session (Examiner notes “intended to be administered to a patient in a single fixed-site fixed-dose treatment session” is a functional limitation. The amount of neurotoxin is not positively required to be administered to a patient in a single fixed-site fixed-dose treatment session. Between 100% and 110% of the amount of neurotoxin in the vessel is fully capable of being administered to a patient in a single fixed-site fixed-dose treatment session due to the structure of the vessel).
In regard to claim 57,
Kumar discloses the vessel of claim 1, wherein said vessel comprises a bottom interior (figure 3A, item 330) that is not parallel to the bottom exterior (exterior of vessel; see figure 3A).
In regard to claim 58,
Kumar discloses the vessel of claim 57, wherein said vessel bottom interior is sloped (see figure 3A).
In regard to claim 59,
Kumar discloses the vessel of claim 57, wherein said vessel bottom interior is concave (see figure 3A).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rubio (U.S. PG publication 20200384090) further in view of Franklin (U.S. PG publication 20130197449).
In regard to claim 3,
Rubio discloses the vessel of claim 2.
Rubio is silent as to wherein said migraine comprises chronic migraine.
Frankin teaches wherein said migraine comprises chronic migraine (paragraph [0080]-[0081]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Rubio to include wherein said migraine comprises chronic migraine, as taught by Franklin, for the purpose of treating chronic migraine (paragraph [0080]-[0081]). As noted above, “intended to be administered to a patient in a single fixed-site fixed-dose treatment session” is functional limitation. The treatment session is not positively required. As supported by Frankin, a chronic migraine treatment session is fully capable.
In regard to claim 4,
Rubio in view of Franklin teaches the vessel of claim 3, wherein said vessel contains between 145 and 200 units of neurotoxin (paragraph [0186] of Rubio, see also paragraph [0081] of Franklin).
In regard to claim 5,
Rubio in view of Franklin teaches the vessel of claim 4, wherein said neurotoxin comprises a Clostridial toxin (paragraph [0018], [0077], and [0186] of Rubio).
In regard to claim 6,
Rubio in view of Franklin teaches the vessel of claim 5, wherein said Clostridial toxin comprises a botulinum toxin (paragraph [0018], [0077], and [0186] of Rubio).
In regard to claim 7,
Rubio in view of Franklin teaches the vessel of claim 6, wherein said botulinum toxin comprises botulinum type A, B, C, D, E, or F (paragraph [0018], [0077], and [0186] of Rubio).
In regard to claim 8,
Rubio in view of Franklin teaches the vessel of claim 7, wherein said botulinum toxin comprises botulinum type A (paragraph [0018], [0077], and [0186] of Rubio).
In regard to claim 15,
Rubio in view of Franklin teaches the vessel of claim 8, wherein said vessel contains 155 units of botulinum type A (paragraph [0186] of Rubio, see also paragraph [0074] and [0081] of Franklin).
Claims 25-29 and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Rubio (U.S. PG publication 20200384090) further in view of Tucker (U.S. PG publication 20100130961).
In regard to claim 25,
Rubio discloses the vessel of claim 1.
Although Rubio discloses the vessel is a syringe, Rubio is silent as to wherein said vessel further comprises a stopper.
Tucker teaches wherein said vessel (figure 3, item 10; paragraph [0058]-[0059]) further comprises a stopper (figure 3, item 34, 32, and 36).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Rubio to include a stopper, as taught by Tucker, for the purpose of enabling liquid to be withdrawn or dispensed from the syringe (paragraph [0006] of Tucker).
In regard to claim 26,
Rubio in view of Tucker teaches the stopper of claim 25.
Rubio in view of Tucker is silent as to wherein said stopper is color-coded for a specific treatment.
Tucker teaches wherein said stopper (figure 3, item 34, 32, and 36) is color-coded for a specific treatment (paragraph [0053]-[0055]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Rubio in view of Tucker to include wherein said stopper is color-coded for a specific treatment, as taught by Tucker, for the purpose of enabling a user to recognize and utilize a syringe properly (paragraph [0053]-[0055] of Tucker).
In regard to claim 27,
Rubio in view of Tucker teaches the color-coded stopper of claim 26, wherein said color comprises at least one of red, orange, yellow, green, blue, indigo, or violet, or combinations thereof (see paragraph [0053]-[0055] of Tucker).
In regard to claim 28,
Rubio discloses the vessel of claim 1.
Rubio is silent as to wherein said vessel is color-coded for a specific treatment.
Tucker teaches wherein said vessel (figure 3, item 10) is color-coded for a specific treatment (paragraph [0053]-[0055]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Rubio to include wherein said vessel is color-coded for a specific treatment, as taught by Tucker, for the purpose of enabling a user to recognize and utilize a syringe properly (paragraph [0053]-[0055] of Tucker).
In regard to claim 29,
Rubio in view of Tucker teaches the color-coded vessel of claim 28, wherein said color comprises at least one of red, orange, yellow, green, blue, indigo, or violet, or combinations thereof (see paragraph [0053]-[0055] of Tucker).
In regard to claim 57,
Rubio discloses the vessel of claim 1.
Rubio is silent as to wherein said vessel comprises a bottom interior that is not parallel to the bottom exterior.
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Tucker teaches wherein said vessel (figure 3, item 10) comprises a bottom interior that is not parallel to the bottom exterior (see figure 3 above).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Rubio to include wherein said vessel comprises a bottom interior that is not parallel to the bottom exterior, as taught by Tucker, for the purpose of enabling coupling of a needle (paragraph [0047] of Tucker).
In regard to claim 58,
Rubio in view of Tucker teaches the vessel of claim 57, wherein said vessel bottom interior is sloped (see figure 3 of Tucker above and analysis of claim 57 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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