Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. This application is a 371 of PCT/EP2022/067922 06/29/2022; FOREIGN APPLICATIONS EP 21183555.8 07/02/2021.
Claims 16-35 are pending.
Response to Restriction Election
2. Applicant’s election of group I and the species in the composition of rocoronium bromide, sodium chloride, hydrochloric acid, optionally sodium hydroxide, and water in the reply filed on June 24, 2026 is acknowledged. The election was made without traverse.
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.
3. Claims 16-32 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 16 defines a composition by “ “Sterilization”, which lacks antecedent basis in the claim. A description of a method step does not make sense in this context. Compounds cannot comprise sterilization steps. See also MPEP § 2112 - MPEP § 2112.02. This is grounded in the statutory distinction, between a physical product and activities that constitute a process (which may include a new “use” of a known invention). Otherwise these composition claims would mutate into method claims. The sterilization limitation is a theoretical inherency outcome based on a method step that is to be conducted. Contrast this with product by process claims which are permitted.
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.
4. Claims 16-32 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. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). See M.P.E.P. § 2163.02. In this case, the skilled artisan would not have reasonably concluded at the time of the invention that applicant was in possession of the entire invention as claimed.
Claim 1 is drawn to “an aqueous room temperature stable composition”, which has various properties including lacking a buffer, a pH range, certain acidity and a functional property of following sterilization having a 2nd pH does not vary more than .2 pH units. They therefore seek to define compounds by particular functional requirements. The specification, however, does not provide any specific correlation between a particular structural property and the claimed function. The description is unclear for a variety of reasons. The specification has a single example that is said to have the functional requirement on page 23 which has no relationship to the claims. This composition has sodium chloride, hydrochloric acid, and water. The specification is devoid of any additional examples showing a correlation of structure to function and is entirely generic with various descriptors of materials that are in the composition but absolutely no correlation with functional requirements of the claims. Applicants provide no guidance for identifying the compounds that meet the requirements, and as such the claims lack written description.
The fact pattern in this case is similar to that in University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (W.D.N.Y. 2003). In Rochester, there were no compounds known to have the required function. The key similarity between the cases, and the one relevant to this ground of rejection, is the fact that no method (other than trial-and-error) is provided for identifying compounds having the desired function. For this reason, the rejection due to lack of written description is proper.
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.
4. Claim(s) 16-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Itsuji US 10,869,876 (cited on the IDS). Itsuji column 11 lines 44-53 teaches the claimed composition:
Reference Example 2
In water for injection , 0.90 g of sodium chloride , 15 g of 0.1 M HCl , and ; 1.0 g of rocuronium bromide were dissolved , and water for injection was further added to adjust the volume to 100 ml . The pH of the obtained preparation was 3.0.
Example 7 at column 12, Table 4 also teaches the composition.
PNG
media_image1.png
213
558
media_image1.png
Greyscale
According to the applicants’ election, “of rocuronium bromide, sodium chloride, hydrochloric acid, optionally sodium hydroxide, and water” they all read on the claims 16-23 which is a de facto admission that the functional requirements in the claims are met by these ingredients. There is no special sauce, it is simply the known drug with salt, acid and water. With regard to the concentration, while the final volume was adjusted to 100 mL, it first had to pass though the claimed range, i.e. 1g/15mL to 1g/100 mL.
5. Claim(s) 16-24, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gil Bejar WO 2014048836 (cited on the IDS). WO ‘836 teaches rocuronium bromide, with Polyhydroxy acid and water. In the preferred embodiment on page 5 line 11 and page 6 1st structure the compound is rocuronium. Most preferred agent is rocuronium bromide listed on page 6 line 11. The concentration of the drug is listed in the description on page 7 lines 36 which is about 1 to 100 , 5 to 50, or 5 to 15 mg/mL. According description on page 7 adding the poly hydroxy acids thermal stability is said to be improved on sterilization in an autoclave as shown on lines 26 to 27 on page 7 and also on page 8. The pH is discussed on page 12 and falls within the claimed range. It is also mentioned that “the pH can be adjusted by addition of suitable acids and bases for example acetic acid and sodium hydroxide.” The addition of the elected species of sodium chloride is discussed as an osmolality control agent on page 14 in particular the paragraph on lines 11 and 16. A container is described on page 18 to be made glass or polymers including polyolefins such as polyethylene and polypropylene and various tradenames are given of such containers.
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.
5. Claim(s) 16-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itsuji US 10,869,876 (cited on the IDS). As discussed above there is no special feature and Itsuji has all the materials of the species election. It is not entirely clear what is in the composition besides the one example of sodium chloride, HCl and water, which are taught by Itsuji. Assuming there were some difference in concentration, finding the right amount is simply routine optimization. The optimal amount of a salt or acid or base or drug concentration can be determined empirically for each individual component using known methods and will depend upon a variety of factors, including, but not limited to, the end use, water quality, route of administration etc. Optimal dosages may be established using routine testing and procedures that are well known in the art.
6. Claim(s) 16-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gil Bejar WO 2014048836. As discussed above Gil Bejar has all the materials of the species election. It is not entirely clear what is in the composition besides the one example of sodium chloride, HCl and water. Assuming there were some difference in concentration, finding the right amount is simply routine optimization. The optimal amount of a salt or acid or base or drug concentration can be determined empirically for each individual component using known methods and will depend upon a variety of factors, including, but not limited to, the end use, water quality, route of administration etc. Optimal dosages may be established using routine testing and procedures that are well known in the art.
7. Claim(s) 24, 29-32, is/are rejected under 35 U.S.C. 103 as being unpatentable over Itsuji US 10,869,876 as applied to claim 16-23 above, and further in view of Weikart US 10,780,021. As discussed above there is no special ingredient in the composition and Itsuji has all the materials of the species election. It is not entirely clear what is in the composition describes as discussed in the 112 rejection, however no particular container is described for rocuronium bromide in Itsuji. According Weikart abstract, “Cycloolefin polymer (COP) containers, including vials or syringes, having a scratch-resistant and anti-static coating on the external wall results in a reduction or prevention of static charge on the articles” which can contain “[0080] Rocuronium Bromide Injection (Zemuron)” “[00126] The plastics containers can have a cylindrical shape or have a rectangular base. Injection containers or screw-closure containers can contain a volume of from 1 to 1000 ml. The volume of the injection containers is preferably from 2 to 100 ml. Ampoules can contain a volume of from 1 to 20 ml. [00127] The plastics injection containers can be closed with rubber stoppers. Suitable materials for the rubber stoppers are chlorobutyl or bromobutyl rubber stoppers. The stopper can be provided with a crimped cap of a lightweight metal, for example of aluminum.” As explained on column 2, “Plastics containers or vials or syringes are frequently used for pharmaceutical preparations. For the production of the preparations, the plastics containers are often sterilized together with the pharmaceutical preparation. They can be sterilized by means of autoclaving…”. It would be obvious to put the Itsuki formulations in a vial or syringe of Weikart.
8. Claim(s) 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itsuji US 10,869,876 and Weikart US 10,780,021 as applied to claim 16-24, 29-32, above, and further in view of Ward “Container and Reconstitution Systems for Lyophilized Drug Products Container and Reconstitution Systems for Lyophilized Drug Products.” Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches, Methods in Pharmacology and Toxicology, Springer 2019. Weikart discloses some plastic syringe packaging but does not discuss glass. Borosilicate glass has been the primary packaging choice for parenteral products since its development more than 100 years ago due to its excellent barrier properties, chemical resistance, regulatory acceptance, and broad range of applications served. This is the main commercial packaging for rocuronium bromide, a glass vial with a stopper. According to page 200 of Ward, “Stoppers may be laminated with fluoropolymer films or coated with silicone-oil-based coatings or fluoropolymer coatings—see Fig. 7: Fluoropolymer Laminate. To minimize interaction of drug product with stopper (either directly with stopper surface, or migration of leachate from stopper), a fluoropolymer film is placed on areas that could contact drug product. To facilitate easy insertion of stopper into vial, a fluoropolymer film is likewise placed on outer surfaces.” Page 202, “Lubricity Coating. To facilitate insertion of stopper into vial and easy handling during fill/finish operation, a coating to enhance lubricity can be placed on stopper surfaces. An example is West B2 coating—a silicone polymer (also called polysiloxane) coating that is applied as a solution, and chemically bonded to stopper surface by a curing process. Fluoropolymer-based coatings can be used also, for example Omniflex® coatings offered by Datwyler Sealing Solutions.” It would be obvious to place the known composition in a plastic or glass vial.
9. Claim(s) 25-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gil Bejar WO 2014048836 as applied to claim 16-24 above, and further in view of Weikart US 10,780,021 and Ward “Container and Reconstitution Systems for Lyophilized Drug Products Container and Reconstitution Systems for Lyophilized Drug Products.” Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches, Methods in Pharmacology and Toxicology, Springer Science+Business Media, LLC, part of Springer Nature 2019. Gil Bejar has a vial but doesn’t talk about the stopper or syringe. These are taught by the other references as discussed above. It would be obvious to place the known composition in a plastic or glass vial or syringe with various coated stoppers.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/DAVID K O'DELL/ Primary Examiner, Art Unit 1621
Prosecution Insights