DETAILED ACTIONStatus of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
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 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.
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 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN1539501A Machine English Translation) hereinafter Wang in view of Lipiainen et al. (“Formulation and Stability of Cytokine Therapeutics” See 10/28/2025 IDS NPL reference #2) hereinafter Lipiainen.
Regarding claims 1-20, Wang is drawn to buccal lozenge of recombinant human interferon alpha 2b for preventing and treating SARS, influenza, hepatitides B and C, viral myocarditis and multiple sclerosis is prepared from recombinant human interferon alpha 2b, lectose, sugar, maltose dextrin, hydroxypropyl methylcellulose, starch and silica gel microparticles through proportionally mixing, sieving, granulating and tableting (abstract).
Wang discloses a troche (which corresponds to "an orally disintegrating tablet") comprising interferon-a and an excipient (Claims 1-4), and describes a process for manufacturing the troche, comprising mixing and sieving what is obtained by conducting a granulation step by sieving the excipient such as lactose, HPMC, silica gel, and the like and what is obtained by conducting a granulation step by adding mannitol to an interferon concentrate, and further adding magnesium stearate and tableting the mixture (Claim 5). Wang also discloses that the above process is used to manufacture troches containing low or high doses of interferon-α2b (Examples 1-6), and that the interferon-a2b-containing troches are administered to healthy subjects to confirm their toxicity and immune-inducing activity (Test Examples 1, 2).
Wang does not explicitly disclose acidifying or cytokines.
However, Lipiainen discloses cytokines are messenger proteins (abstract) and when manufacturing protein preparations such as interferon-a, adding citric acid to chelate metal ions present as impurities in excipients prevents oxidative damage to the protein and increases stability (page 312, left column, third paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings as previously disclosed by Wang, to incorporate adding citric acid, as previously disclosed by Lipiainen, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Wang and Lipiainen are both in the field of cytokine formulations including interferon, and Lipiainen teachings developing stable cytokine formulations, thus combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
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 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. 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 the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615
Prosecution Insights