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 .
Election/Restrictions
Applicants’ election of Group II (claims 5-15) drawn to a polymeric compound of glucuronic acid comprising at least one phenolic group obtainable by the method as defined in claim 2, is acknowledged. The election was made with traverse.
The grounds for traversal as indicated by Applicants, is that the reliance on Calabro et al. (WO 2004/063388) as disclosing the special technical feature is misplaced. More specifically, Applicants argue that Calabro is silent about using a radical coupling reaction polymerization with linking of a phenol compound to the hydroxyl groups of the polymeric compounds of glucuronic acid. The Examiner find this argument persuasive in view of the claim amendment to claim 5.
Therefore, the requirement for restriction is hereby withdrawn.
Accordingly, claims 1-23 are under current examination.
Status of Claims
A new claim set was filed on 3/2/26 with the following:
Amended claims
2, 4-5, 8-9 and 11
Newly canceled claims
Newly added claims
Previously canceled claims
Instantly withdrawn claims
Claims under instant examination
1-23
Claim Objections
Claims 1-23 are objected to because of the following informalities: Independent claims lack the article “A” and the dependent claims lack the article “The” at the beginning of each claim. See MPEP 608.01(n)(IV). See Interview summary herein for suggested amendments in order to obviate these claim objections.
Claim 7 is objected to because of the following informality: it recites “…a cross-linking catalyst consisting in an oxidase…”. The ordinary wording is “consisting of” and such amendment is suggested in order to obviate this claim objection.
Claim 8 is objected to because of the following informality: it recites “…glucuronic acid is associated to an oxidase…”. The ordinary wording is “associated with” and such amendment is suggested in order to obviate this claim objection.
Claim 8 is objected to because of the following informality: it recites “…cross linking catalyst is chosen from the group consisting of oxydo-reductase…”. The Examiner suggests the following amendments in order to correct spelling and not duplicate the verb: “…cross linking catalyst ido-reductase…”.
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.
Claims 2-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2 and 4-23 are unclear in that claim 2 recites: “…by radical coupling, so as to obtain a polymeric compound of glucuronic acid of formula (E)…”. It is unclear if this is the same “polymeric compound of glucuronic acid” recited in line 2 or a different one. Assuming it is the same one, the Examiner suggests changing the article “a” to “the” to make such clear.
Claim 3 is unclear in that it recites “…providing a polymeric compound of glucuronic acid (PGU) of formula (B)…”. However, claim 3 or claim 1, which claim 3 is dependent from, do not recite what formula (B) is; specifically, what is the chemical structure of a PGU of formula (B). Therefore, the metes and bounds of the claim are indefinite.
Claims 6-23 are unclear in that claims 6-7 recite “Solution comprising water and a polymeric compound of glucuronic acid as defined in claim 5. It is unclear if this is the same “polymeric compound of glucuronic acid” recited in claim 5 or a different one based on the “a” article. Assuming it is the same one, the Examiner suggests changing the article “a” to “the” to make such clear.
Claims 8-9 is unclear in that claim 8 recites: “…glucuronic acid is associated to an oxidase …”. It is unclear if this is the same “oxidase” recited in claim 7, which claim 8 is dependent from, or a different one. Assuming it is the same one, the Examiner suggests changing the article “an” to “the” to make such clear.
Claim 10 is unclear in that it recites: “…associated to a compound containing H2O2…”. It is unclear if this is the same “compound containing H2O2” recited in claim 7, which claim 10 is dependent from, or a different one. Assuming it is the same one, the Examiner suggests changing the article “a” to “the” to make such clear.
Claims 8-9 and 13 are unclear in that claims 8 and 13 recite the limitation "the mixtures thereof”. There is insufficient antecedent basis for this limitation in the claim. Therefore, it is unclear what this limitation refers to and how to interpret the claim. The Examiner suggests amending the article “the” to “a”.
Claims 16 and 18-19 are unclear in that claim 16 recites: “…providing a gel-forming composition as defined in claim 7…”. It is unclear if this is the same “gel-forming composition” recited in claim 7, which claim 16 is dependent from, or a different one. Assuming it is the same one, the Examiner suggests changing the article “a” to “the” to make such clear.
Claims 17 and 20 are unclear in that claim 17 recites: “…providing a gel-forming composition as defined in claim 15…”. It is unclear if this is the same “gel-forming composition” recited in claim 15, which claim 17 is dependent from, or a different one. Assuming it is the same one, the Examiner suggests changing the article “a” to “the” to make such clear.
Claims 21-23 provide for the use of “the hydrogel structure according to claim 21” or the use of “the cell-containing hydrogel structure according to claim 23” but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 21-23 are unclear in that claims 21 and 23 are dependent on itself. For example, claim 21 recites “Use of the hydrogel structure according to claim 21”. Since claim 21 does not previously recite a hydrogel structure, it is unclear what hydrogel structure is being referred to here. Therefore, it is unclear what this limitation refers to and how to interpret the claim. The same scenario is presented in claim 23, which recites “Use of the cell-containing hydrogel structure according to claim 23…”.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefinite concerns outlined above.
Claim Rejections - 35 USC § 112(d)
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.
Claim 14 is 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.
Claim 14 recites “…wherein said biodegradable polymer is a gelatin derivative…”. Claim 14 is dependent on claim 13, which recites a Markush grouping for the biodegradable polymer that does not include gelatin derivative. The Examiner suggests amending claim 13 to recite “…gelatin or gelatin derivative…” and amend the article “a” before “gelatin derivative” in claim 14 to “the”. 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.
Claim Rejections - 35 USC § 102
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) 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Calabro et al. (WO 2004/063388; published: 07/29/04; in IDS dated 11/09/23).
Calabro is directed to dihydroxyphenyl cross-linked macromolecular network useful in artificial tissue and tissue engineering [Abstract]. Calabro teaches wherein the macromolecule is hyaluronan or hyaluronic acid (HA) and the hydroxylphenyl group is in the form of tyramine [p. 16]. Calabro teaches that HA is composed of repeating pairs of glucuronic acid (glcA) and N-acetylglucosamine (glcNAc) residues linked by a β1,4 glycosidic bond [p. 16]. Calabro teaches a reaction scheme:
PNG
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, wherein the claimed PGU is B and the phenolic compound is D and such reaction produces a phenol group onto the carboxylic acid of glucuronic acid [p. 16] and [see Example 1 for method steps].
Therefore, by teaching all the limitations of claims 1 and 3, Calabro anticipates the instant invention as claimed.
Examiner’s Note
Claim 2 and its dependent claims are free of the prior art. The Examiner called the Attorney of Record and proposed Examiner’s amendments in order to place the application in condition for allowance (See Interview Summary for details).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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