DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 52-70 are pending upon entry of amendment filed on 5/20/26.
Applicant’s election of Group I drawn to claims 52-70 without traverse in the response filed on 5/20/26 has been acknowledged.
Although claims 71-72 is indicated withdrawn, the claims filed on 5/20/26 fail to reiterate claims 71-72, the claims 71-72 are considered canceled.
4. Applicants' IDS filed on 11/21/23 has been considered. The copies of non-patent literature and foreign patents are in U.S. Application numbers 15/542,921 and 16/788,218.
5. 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.
6. Claims 61, 62, 64 and 65 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 pre-AIA the applicant regards as the invention.
The use of the term “optionally” in claim 61 and “such as” in claims 62 and 64, respectively, renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claims 65 recite the broad recitation viscosity with narrower recitation of viscosity, together.
7. 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.
8. Claims 52-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for administering composition comprising human gamma globumin (HGG) at a concentration from 10-about 300mg/ml and a nicotinic acid, nicotinamide and nicotinic acid sodium salt at 10mg/ml in the presence of phosphate buffer at pH 6, but does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use other than nicotinic acid, nicotinic acid salt and nicotiniamide at 10mg/ml to reduce the viscosity of antibody composition under 100cP.
Example 7 in the instant application in p. 152-155 shows measurements of viscosity of nicotinic acid derivatives or analogues at concentration of 10mg/ml in the presence of phosphate buffer with HGG. Tables 13-15 show different buffers with the same excipient concentrations. The nicotinic acid at higher concentration of HGG does not establish the viscosity under 100cp (note nicotinic acid show 178 with 342 mg/ml of HGG in table 15). Further in table 14, histidine buffer is used with the exact same excipient concentrations but did not exhibit less than 100cp of viscosity.
Further, even though huge genus of viscosity reducing agents are disclosed in the specification in p. 68-78, other than nicotinaminde and nicotinic acid salt, no analogs or derivatives are specified. None is studied at the specified concentration ranges than nicotinic acid Na salt and nicotinamide. As seen in the tables 13-15, the different buffer has different effects toward viscosity even with the same concentrations of antibody and nicotinic acid, nicotinamide and nicotinic acid salt.
Moreover, the claims of the instant application is not limited to the single viscosity reducing agent with an antibody but combinations of various reducing agents. As seen in Table 24 of the instant application, caffeine and nicotinic acid salt combination, tryptophan and nicotinamide combination did not show the viscosity under 100cP at concentration of 280mg/ml of antibody even in the presence of phosphate buffer. Some combinations even though they showed viscosity reducing effect when added as a single component, combinations worked mutually exclusive as evidenced in table 24 of applicant’s own study.
The table 27 (p. 179) shows the most prominent combination of tryptophan and nicotinic acid with antibody concentration of 350mg/ml did not exhibit viscosity under 100cP.
In addition, U. S. Pub. 2015/0071925 discloses various therapeutic antibodies with viscosity lowering agents. The ‘925 publication discloses the Erbitux (e.g. therapeutic antibody of 150kD) compositions in the presence of nicotinamide (nicotinic acid analog or derivative that is encompassed by the claimed invention) of 150mM with 232 mg/ml of antibody showing the viscosity is 292cP (note Table 37 p. 40). As such, no protein other than human gamma globulin (HGG) shows the claimed viscosity. While the viscosity reducing agent is concentration dependent, no other concentration than 10mg/ml is studied. The limited guidance presented in the specification of the current application cannot extrapolate the claimed ranges of the concentrations of viscosity reducing agents, proteins at claimed concentration ranges. Applicant is required to amend the claims accordingly.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
9. 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.
10. 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
11. Claims 52-70 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2016/0074515 (IDS reference).
The ‘515 publication discloses administration of antibody compositions comprising antibody at 280 mg/ml of BGG in the presence of 15mg/ml of caffeine showing 0.69 (note Tables 11-13, claim 38). Given that the citrate, phosphate and /or histidine is used as buffer of 1-50mM, it is obvious to use citrate as salt (Table 13, 15, claims) and it is obvious over the limitations of claim 52-70.
Further, the ‘515 publication teaches addition of additional excipients such as imidazole, nicotinamide, tryptophan as in claims 52-70 of the instant application ([0051]). In addition, the ‘515 publication teaches the protein is an antibody and meets the limitations of the claimed invention ([0020-00021]). The antibody formulations can either be liquid or lyophilized (p. 8-10) and other excipients including amino acid, amines, surfactants or polyols may be added (p. 8, claims).
The ‘515 publication teaches various viscosity lowering agent and their values in cP in Examples and Tables. The tables include amino acids such as arginine, lysine, tryptophan, creatines and combinations thereof (note claims allow one or more viscosity lowing agents).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to add and/or combine viscosity lowering agents especially with the tested cP values available to achieve viscosity of interest.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the addition of elastin antibody improves production of elastin that is necessary to treat elastin degradation. It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhovan, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. No claims are allowable.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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, Misook Yu can be reached at 571-272-0839. 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.
Yunsoo Kim
Patent Examiner
Technology Center 1600
July 9, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
Prosecution Insights