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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/22/20 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 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.
Claim 3 recites the limitation "the polymeric bag" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 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.
Claim(s) 1-13, 21-25, 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Akasapu et al (US 2019/0290602 A1 hereafter Akasapu) Okada et al (US 2015/0368022 A1 hereafter Okada) Akasapu discloses a method for protecting an oxygen sensitive active agent such as epinephrine, comprising placing the polymeric container into an overwrap , where the polymeric container comprises the epinephrine, placing a metal-containing oxygen scavenger in the space between the polymeric container and the overwrap and sealing the overwrap [0015, 0029], meeting limitations of claims 1, 2, 21, 22. The polymers of the container include polyvinyl chloride and various copolymers of ethylene-propylene [0037], meeting limitations of claims 3, 23. The polymeric bag is a flexible I.V. bag with a capacity of at least 100 mL [0037], meeting the limitations of claims 4, 24. The overwrap can be metalized such as aluminum [0036], meeting limitations of 5, 25. Regarding the degradation of the epinephrine, the method results in impurities being less than 1& 4 weeks when stored at 25 oC [Table 2, 12], meeting limitations of 12. The reference discloses the kit to accomplish this method which comprises an overwrap, polymeric container and a metal-containing oxygen scavenger in the space between the polymeric container and the overwrap, where the overwrap can also be metal containing [0035-0037, 0048].
The reference discloses the use of an overwrap, a polymer container comprising a catecholamine, and a metal-containing oxygen scavenger in the space between. The reference discloses aluminum as the metal overwrap but is silent to the specific metal of the instant claims. The use of iron as a, oxygen scavenger is known in the in art as seen in the Okada patent.
Okada discloses an oxygen absorbing, multilayered body comprising an active agent that is susceptible to degradation by oxygen [abstract]. The drug can be epinephrine in solution form [0351]. The solution can be contained in a polymeric body and wrapped in an aluminum foil bag in order to block oxygen transmission [0378]. Including the bag can be iron powder acting as the oxygen absorbing components in the film [0431] It would have been obvious to include the iron of Okada into the method and kit of Akasapu as they solve the same problem and iron would enhance the oxygen stopping properties of the method.
Regarding the amount of the formaldehyde produced by condensation and the supposed puncture that might lead to such condensation, it is the position of the Examiner that the prior art would meet the limitation of the prior art. Firstly, the condensation occurs if the bag is punctured or poorly sealed. In the latter case, the Akasapu discloses that the method results in less than 1% contaminations and impurities over the same period of time in storage. This means that the seal is sufficient to met the limitations of the claims. The seal, metal-containing oxygen scavenger and overwrap are all sufficient to meet the limitations of the claims. The method is accomplished by arranging these components along with epinephrine in a polymeric container. The same polymers are provided int eh container, as well as the same size of the container, and metal-containing oxygen absorbing material. The same components are arranged in the same way, for the same purpose of reducing impurities. Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Further, the Office does not have the facilities for examining and comparing applicant’s product with the product of the prior art in order to establish that the product of the prior art does not possess the same material structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable method for protecting catecholamine from degradation. It would have been obvious to combine the iron of Okada into the kits and method of Akasapu to add to and increase the oxygen blocking properties of the combination. One of ordinary skill in the art would have looked to the Okada patent to improve the protection of Akasapu as they solve the same problem.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618