DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 07 July 2025 in which claims 1-5 were amended to change the scope and breadth of the claims, and claims 6-9 were newly added.
Claims 1-9 are pending in the current application. Claims 1-4 and 6-9 are withdrawn as being drawn to a non-elected invention, restricted by original presentation, see below. Claim 5 is examined on the merits herein.
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 .
Election/Restrictions
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits.
Moreover, since applicant has received an action on the merits for the inventions as originally filed, according to MPEP § 819, the general policy of the Office is not to permit the Applicant to shift to, or include, additional claims claiming another invention, such as in amended claims 1-4 and newly added claims 6-9.
Newly submitted claims 1-4 and 6-9 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
In the present case, the original invention (originally presented claims 1-5) is drawn to a product/composition comprising specified compounds herein, whereas the invention of newly submitted claims 1-4 and 6-9 are drawn to a method for using a polymer or a method for treating fibrosis. The original invention and the newly claimed invention are separate and distinct, related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product (MPEP § 806.05(h)). In the present case, for example, the compound of chemical formula (1) or (2), recited in claim 4, can be used in vitro, to study GlcNAc-binding activities of proteins including vimentin, desmin, glial fibrillary acidic protein (GFAP) and peripherin (abstract; see Ise et al. of record). Thus, currently presented claims 1-4, 6-9 and amended added claim 5 fall into two different statutory classes.
Accordingly, claims 1-4 and 6-9 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Withdrawn Rejections
Applicant’s amendment, filed 07 July 2025, with respect to the rejections of claims 1-5 under 35 U.S.C. § 102(a)(1), as being anticipated by Ise et al., has been fully considered and is persuasive because claim 5 has been amended to recite “an oral or parenteral dosage form”, and Ise et al. teach immobilizing the compound on a maleimide cross-linker conjugated sensor chip CM5. The rejection is hereby withdrawn.
New Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 07 July 2025, where the limitations in pending claims 1-5 as amended now have been changed and claims 6-9 have been newly added. Therefore, rejections from the previous Office Action, dated 04 April 2025, have been modified and are listed below.
Claim Rejections - 35 USC § 112(b)
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.
Claim 5 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.
The recitation “an oral or parenteral dosage form”…”a polymer comprising….a carboxy group-containing radically polymerizable unit as an active ingredient” in amended claim 5 renders the claim herein indefinite.
Generally, a “polymerizable unit” is a functional group that has not yet been polymerized. Yet, the claim already calls this composition “a polymer comprising”. This general understanding of the meaning of “polymerizable” is supported by the present Specification.
According to the Specification, “a carboxy group-containing radically polymerizable unit” include “acrylic acid, methacrylic acid, itaconic acid, maleic acid, crotonic acid, 2-carboxyethyl acrylate, and 2-carboxyethyl methacrylate” (see p.14:11-13).
Yet, the examples in the Specification are all directed towards preparing a polymer from a carboxy-containing radically polymerizable unit, where the final product is no longer considered “polymerizable”, and no longer contains the double bonds found in the above functional groups. This is particularly confusing since claim 5 appears to be directed towards a final product to be used as an “active ingredient” in an “oral or parenteral dosage form”. Yet, the structural composition of claim 5 appears to be directed towards the starting material. Appropriate correction is requested.
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.
Claim(s) 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Botha et al. (Analytical and Bioanalytical Chemistry, 2018, vol. 410, pp. 4259-4273, cited in PTO-892).
Botha et al. disclose the preparation of hydrophobically modified hyaluronic acid (HA; title). HA is a linear glycosaminoglycan consisting of repeating disaccharide unit comprising β-(1,4)-D-glucuronic acid (GlcA) and β-(1,3)-N-acetyl-D-glucosamine (GlcNAc) units (p.4259, second para). Modified HA can be used in drug delivery applications. Botha et al. teach HA is usually modified at one of its four hydroxyl groups, and reactions include amidation, esterification, etherification and oxidation (p.4259, third para).
Acrylate-modified HA with DS ranging from 0 to 3.4 were used as received (p.4260, Materials). FTIR measurements were obtained on the samples as solids and films, wherein the solids and films were produced by dissolving/dispersing the samples in pure water (p.4260-4261, bridging para).
Table 1, HAM 05 is directed to an acrylate-modified HA having a MW of 36,360 and DS of 2.2:
PNG
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198
246
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Greyscale
(p.4261; image taken from Fig. 9, fraction 1). The unmodified hyaluronic acid disaccharide has a molar mass of about 401.30 g/mol. HAM 05 has a reported MW of 36,360 g/mol. Thus, there are about 90 repeating disaccharide units, and therefore about 45 N-acetylglucosamine groups “per molecule”.
HAM 05 is a polymer that comprises an N-acetylglucosamine unit and an acrylic acid moiety, i.e. a carboxy group-containing radically polymerizable unit.
The reference discloses dissolving it in water (i.e. a pharmaceutically acceptable carrier).
The recitation “an oral or parenteral dosage form” in claim 5 is broadly and reasonably interpreted to include an aqueous solution of the polymer.
The recitation “as an active ingredient” in claim 5 does not alter the structural feature of the polymer itself, and does not have patentable weight.
Thus, the disclosure of Botha et al. anticipates claim 5 of the present application.
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.
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) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Botha et al. in view of Oh et al. (Bioconjugate Chem., 2008, vol. 19, pp. 2401-2408, cited in PTO-892).
Botha et al. teach as discussed above.
Botha et al. do not expressly disclose the HA-acrylate as an active ingredient (claim 5).
Oh et al. teach the preparation of aminoethyl methacrylated HA (HA-AEMA) for conjugation of HA to a peptide to give an HA-peptide conjugate as a novel drug candidate for the treatment of inflammatory diseases such as sepsis, asthma, and rheumatoid arthritis (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the HA-acrylate of Botha as an active ingredient, because Oh et al. teach they can be conjugated to give an HA-peptide as an active agent for treating inflammatory diseases such as sepsis, asthma, and rheumatoid arthritis.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is 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.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699