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 .
Receipt is acknowledged of Applicant’s Amendment filed on 08/10/2026.
Claims 1-5, 7, 9, 13, 15-18, 20 have been amended.
Claims 25-28 have been added.
Claims 22-23 have been canceled.
Claims 1-5, 7-9, 12-21, 24-28 are pending in the instant application.
Claims 7-9, 15-21, and 28 are withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112, 1st paragraph
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.
Claims 1-5,12-13, 15-20 and 24-27 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 synthesizing the compounds in claim 14, does not reasonably provide enablement for all the compounds recited in independent claim 1. 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 the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All of the factors have been considered with regard to these claims, with the most relevant factors discussed below:
1) The breadth of claims: The instant claims are directed to compounds with a laundry list of attached functional groups, such as X, X', and Y are each independently a direct bond, -C(0)-, -C(0)0-, -C(O)NR-, -0-, -S-, or -NR-, etc. This is a very broad claim, one that is not supported by the instant specification.
4) The amount of direction provided by the inventor: Applicant provided disclosures on synthesizing the compounds in claim 14, wherein X' and X is-S-; or wherein X' is -0-, then X is a direct bond. However, there is a substantial gap between these specific functional groups recited in claim 14 versus the laundry list of functional groups recited in claim 1. Consequently, a burdensome amount of research would be required by one of ordinary skill in the art to bridge this gap.
5) Predictability of the art: The synthesis of compounds are unpredictable when the functional groups are different; thus, undue burden experiments are required to synthesize the laundry list of functional groups as claimed by Applicant.
6) The presence or absence of working examples: Applicant provided disclosures on synthesizing the compounds in claim 14, wherein X' and X is-S-,; or wherein X' is -0-, then X is a direct bond. Overall, applicant fails to provide examples showing how to synthesis the other compounds with different functional groups. Therefore, the practitioner would turn to trial and error experimentations to make the compounds with the laundry list of functional groups.
In summary, Applicant has not provided on how to make every compounds as claimed by Applicant.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-5, 12-14, 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over MANEZ et al (WO 2015/007326).
Regarding claims 1-5, 12, 25-26, MANEZ teaches the prior art had known of a compound for the treatment of inflammatory diseases comprised of: polylysine backbone (see pg. 8) and a terminal α-galactosyl moiety (see abstract; claim 1 and 7; and figure on pg. 8, wherein the figure is provided below):
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Pertaining to Applicant’s claim 1, MANEZ’s “n” is 900-1200, and 250, wherein 250 is close to Applicant’s claim 1 recitation of “a” is 300 to 700; and MANEZ’s “x” is 0.23-0.28, which overlaps Applicant’s claim 1 recitation of “r” is 0.09 to 0.35.
The reference does not specifically teach exact ranges of “a” and “r” as claimed by Applicant, which represents the number of repeating units in a polymer. The number of repeating units in a polymer composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal repeating units in a polymer in order to best achieve the desired results, such as treating inflammation. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of repeating units would have been obvious at the time of Applicant's invention.
Regarding claims 13-14, MANEZ teaches terminal α-galactosyl moiety is linear B-2 trisaccharide (see pg. 19, line 31).
Regarding claim 27, MANEZ teaches Gal-a1,3Gal-B1,4GlcNAc (see pg. 20, line 3).
Allowable Subject Matter
Claim 1 could be allowable, if dependent claims 14 and 26 are amended into claim 1.
Response to Arguments
Applicant argues that Manez discloses the GAS914 compound, which has an "a" value of 1,000 and an "r" value of 0.27, which corresponds to a total number of 270 aGal units per polymer. A person of ordinary skill in the art (POSA) would expect that increasing the number of aGal units per polymer would increase the ability of the polymer to sequester anti-aGal. In contrast, as shown in the table below, the inventors observed that the efficacy of anti-aGal IgE increased for an average sum of lysine units ("a"), which corresponds to the degree of lysine polymerization (DP) in the polymeric glycoconjugate compound, equal to that of GAS914 (i.e., 1000), when the percentage of lysine units containing aGal ("r") was reduced. Applicant submits that a POSA would not expect that a 33% reduction in total number of aGal units with respect to GAS914, in the case of compound DPI000-RA0I 18, or a 66% reduction in total number of aGal units with respect to GAS914, in the case of compound DPI000-RA0I 12, would result in an increase in anti-aGal IgE inhibition. Applicant respectfully points out that amended claim I recites that the average sum of lysine units ("a") must be either 300-700 or 100, which excludes GAS914. As the Examiner indicates in the Office Action, Manez discloses polymers in which the "a" value would be between 900 and 1200, or 250, i.e., values that are above, below, or different with respect to the currently claimed values. Applicant respectfully points out that the disclosures in Manez relate to treatments of inflammation, in particular sepsis and reducing cytokines (Manez, at page 3, lines 9-11), which include the removal of anti-aGal antibodies IgG and IgM (Manez, description page 8, lines 1-5; example I; and FIG. ID) by using compound GAS914. No other antibody removal is disclosed in Manez and particularly IgE is not mentioned except for representing a specific class of antibody in its background section. Thus, Manez solely relates to the use of GAS9 l 4 to reduce levels of IgG and IgM antibodies.
The Examiner finds this argument unpersuasive, because the teaching of MANEZ is not limited to the examples, similar to Applicant’s claims are not limited to Applicant’s example. Especially, when MANEZ teaches lower units, such as 250 can be used.
Applicant argues that the inventors further explored the design of polymeric glycoconjugate compounds, not only with a low aGal epitope load, but also with a lower
number of polymerized lysine units. The table below shows that reducing the number of lysine units with respect to GAS914 (e.g., 40% reduction when a=600 or even a 90% reduction when a=l00) and aGal load yielded polymeric glycoconjugate compounds that unexpectedly provided a robust and preferential IgE inhibitory effect. As shown in the specification, the polymeric glycoconjugates according to the claims were unexpectedly more effective at inhibiting IgE than inhibiting IgA or IgG. See, e.g., FIGS. 15, 16 and
17. Applicant respectfully submits that this preferential binding to anti-aGal IgE antibodies, which was unexpected in view of the disclosures in Manez, has been incorporated into amended claim 1, which recites that the "polymeric glycoconjugate compound preferentially binds anti-aGal IgE antibodies over anti-aGal IgA and IgG anti-aGal antibodies." Applicant submits that in addition to being unexpected, the obtained results were not the result of routine experimentation because the selection of appropriate "a" and "r" values was not solely based on the capacity of the polymeric glycoconjugate compounds to bind anti-aGal IgE antibodies. The process also required adjustment of the polymeric glycoconjugate compounds' rheological properties to obtain compounds as claimed that are suitable for the manufacture of medicaments. For example, lowering the number of lysine residues as recited in the claims lowers the viscosity of the polymeric glycoconjugate compound, and a compound with lower viscosity is easier to manipulate. Furthermore, having a smaller lysine backbone as recited in the claims reduces polymerization time, which reduces costs, and the lower polymerization time can reduce the polydispersity index of the polymeric glycoconjugate compound, conferring desirable characteristics for the parenteral administration of the polymeric glycoconjugate compound.
The Examiner finds this argument unpersuasive, because in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In this instance, Applicant’s examples showed this unexpected result were only a = 100 or 600, wherein Applicant only compared to a = 1,000 but the prior art teaches using a =250. Additionally, Applicant’s examples used the general structure having X and X’ = -S- (see Applicant’s Fig. 1), but Applicant’s claim 1 recites X and X’ can be -C(O)-, -C(O)O-, -C(O)NR-, etc.
Conclusion
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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