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 .
Applicant’s Response Dated February 25, 2026
In the Response dated February 25, 2026, claims 105, 107, and 110-111 were amended, and claim 106 was canceled. Claims 105 and 107-128 are pending. An action on the merits of claims 105 and 107-128 is contained herein.
The provisional rejection of claims 105-114 and 119 under 35 U.S.C. 101 as claiming the same invention as that of claims 121-125, 127-131, and 134 of copending Application No. 18/351,367 has been withdrawn in view of applicant’s argument that the ‘367 application features “an autoantigen which has been engineered…”. Applicant’s argument is persuasive. Thus, the rejection has been withdrawn.
The rejection of claims 105, 107-111, and 115-128 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been rendered moot in view of applicant’s amendment dated February 25, 2026. Claim 105 has been amended to include the clause “wherein the engineered hypoimmunogenic biotherapeutic is of formula (I):…m is an integer of 2 or more”. Thus, the rejection has been withdrawn. In view of applicant’s response, the examiner interprets the functional limitation “a biotherapeutic which has been engineered to comprise an elevated amount of…while retaining therapeutic activity” to be inherent to a compound of formula (I).
The rejection of claims 112-114 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained for the reasons of record. Claims 116-118 were erroneously included in the rejection. The rejection as it relates to claims 116-118 has been withdrawn.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 105, 108-111, and 119 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brossmer et al. US 9,539,336 B2 (Brossmer).
Brossmer teaches sialic acid derivatives of formula (I):
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170
610
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.
See columns 1-2. Brossmer also relates to the use of a sialic acid derivative of the formula (I) in a method for linking with a cargo (column 4, lines 4-25). For example, low molecular weight active ingredients (low molecular weight pharmacologically active substances), radioactively labeled substances, cytostatics, RNA, DNA, proteins, or another therapeutically applicable cargo are linked. Brossmer further teaches sialic acid derivative 43 which corresponds to a compound of instant formula (I).
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Compound 43 of Brossmer is embraced by instant formula (I) wherein, X is a sialic acid group (e.g.,
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124
234
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), n is 1, L is a linker (e.g., a branched linker), m is 2, and Y is a biotherapeutic (e.g., poly lysine). Brossmer is silent on if compound 43 “has been engineered to comprise an elevated amount of Sialic acid-binding immunoglobulin-type lectin (Siglec) ligand relative to a corresponding unengineered biotherapeutic while retaining therapeutic activity”; however, this deficiency would not have been inherent to a compound of instant formula (I). Thus, claims 105, 108-111, and 119 are anticipated.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
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.
Claim(s) 120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brossmer et al. US 9,539,336 B2 (Brossmer) as applied to claims 105, 108-111, and 119 above, further in view of Shukla, Swet Chand, et al. "Review on production and medical applications of ɛ-polylysine." Biochemical Engineering Journal 65 (2012): 70-81 (Skukla).
Brossmer also relates to the use of a sialic acid derivative of the formula (I) in a method for preparing polyvalent ligands (column 5, lines 5-21). By linking with a polyvalent carrier molecule, active substances can be prepared having improved properties. These substances can be used for use in a method for modulating the immune system, for example in vaccinations and also for the treatment of diseases whose course or activity can be positively influenced by the Siglec inhibitors, especially allergies, autoimmune diseases, chronic inflammation, paraplegia, multiple sclerosis, cancer, viral diseases such as AIDS, bacterial diseases, for example streptococci, parasitic diseases such as Chagas disease, diseases in which the immune response is impaired in the context of B cell activation such as common variable immunodeficiency (CVID) and IgA deficiency, in diseases of the blood-forming organs and of the blood as well as in cancer, such as lymphomas and myelomas.
Brossmer differs from the instantly claimed invention in that Brossmer does not explicitly teach a method of treatment comprising the administration of compound 43 to an individual in need thereof; however, this deficiency would have been obvious in view of the teachings of Skukla.
In the instant case, the references may be combined to show obviousness because Brossmer and Skukla are each drawn to polylysine. They are from the same field of endeavor, and/or are reasonably pertinent to a method of treating an individual suffering from a disorder or disease treatable by administration of a biotherapeutic agent.
Skukla teaches the use of polylysine as a lipase inhibitor (page 77). Skukla discloses that Kido et al. reported the inhibitory activity of poly lysine (PL) on porcine and human lipase at a concentration of 10–1000 mg/l. In addition, 10–1000 mg/l -PL was found to destroy the stability of the substrate emulsions, with maximum activity at 100 mg/l. It inhibits human and porcine pancreatic lipase activity in substrate emulsions containing bile salts and phosphatidylcholine, it also destroys the emulsifying activity [140]. Tsujita et al. found that -PL and taurocholate, forms a surface-active complex that binds to emulsion particles, thereby retarding lipase adsorption and triacylglycerol hydrolysis both in vivo and in vitro. They concluded that -PL acts as an anti-obesity agent and it was found that inhibition increases with the degree of -PL polymerization
It would have been obvious to administer compound 43 of Brossmer to an obese subject in order to treat obesity. Compound 43 of Brossmer contains polylysine. One would have been motivated to do so with a reasonable expectation of success as Skukla teaches the use of polylysine as a lipase inhibitor and that polylysine may be useful in the treatment of obesity.
All of the instant limitations are taught by the combination of Brossmer and Skukla. A person of ordinary skill in the art would have had a reason to combine the teachings of Brossmer and Skukla. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Brossmer and Skukla. Thus, claim 120 would have been obvious based on the preponderance of the evidence.
Conclusion
Claims 105 and 107-128 are pending. Claims 105, 108-114, and 119-120 are rejected. Claims 107, 115-118, and 121-128 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/
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