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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 6-4-26 has been entered.
Claims 1, 4-9 and 12-15 are pending and under examination.
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 7 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 6 is drawn to “[a]n antibody formulation, characterized by comprising: (1) 2-100 mg/mL of a humanized anti-IL-6 receptor antibody comprising a heavy chain shown in SEQ ID NO. 1 and a light chain shown in SEQ ID NO. 2; (2) a buffer system comprising 5-20 mM histidine salt; (3) a surfactant comprising 0.45-0.65 g/L polysorbate-80; (4) a stabilizer comprising a combination of 40-200 mM arginine hydrochloride and 15-70 g/L sucrose; (5) water for injection; and having a pH of 6.0-6.4, characterized in that, wherein the formulation also comprises a base.” (emphasis added).
The phrase “characterized in that” is not defined / explained by in the teachings of the instant specification.
The amino acid histidine is a base at physiologic pH (around 7.4) but is present as both a base and an acid at a pH near its pKa (around 6.0)(see attached BOC Sciences, pages 1-9, retrieved from the internet on 7-2-26, cited herewith). It would not be clear to the skilled artisan if the phrase “characterized in that, wherein the formulation also comprises a base” was meant to imply that, in this dependent claim the pH is predominately more basic, and thus the “histidine salt” is primarily basic as well, or something else, e.g., that the formulation comprises a base that is entirely different from histidine?
Given these various interpretations the metes and bounds of claim 6 would be unclear to one of ordinary skill in the art. One way to clarify the meaning of claim 6 would be, e.g., if it were to instead recite “The antibody formulation of claim 1, wherein the formulation further comprises a base other than histidine.”
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.
Claims 7 and 8 are 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.
As to claim 7 reciting “[t]he antibody formulation according to claim 1, characterized in that, the pharmaceutical dosage form of the antibody formulation is an injection formulation,” it would be unclear to the skilled artisan how the antibody formulation according to claim 1 could be said to anything other than a “an injection formulation” in that any composition comprising “water for injection” must also be considered to be “…characterized in that, the pharmaceutical dosage form of the antibody formulation is an injection formulation.”
Likewise, as to claim 8 reciting “[t]he antibody formulation according to claim 1, characterized in that, the formulation remains stable for at least one month at room temperature,” it would be unclear to the skilled artisan how the antibody of claim 1 could not be considered to be “characterized in that, the formulation remains stable for at least one month at room temperature” given the teachings of specification at Example 7.
Thus, claims 7 and 8 are of improper dependent form for failing to further limit the subject matter of the claim upon which they depend.
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.
Claims 1, 4, 5, 9 and 12-15 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
Prosecution Insights