Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 02 February 2026.
CLAIMS UNDER EXAMINATION
Claims 1, 8, 14-16, 18-19 and 21-24 have been examined on their merits.
PRIORITY
Foreign Priority Document 1106742.8, filed on 20 April 2011, is acknowledged.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 112
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.
Claims 1, 8, 14-16, 18-19 and 22-24 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to recite “the cross-linker groups comprise a compound of formula X[CO2H]n, wherein n is from 2 to 6”. This is interpreted to mean a crosslinker comprising 2-6 carboxylic acid groups. The claim also recites “the cross-linker groups comprise dicarboxylic acids”. A dicarboxylic acid comprises two carboxylic acid groups (n=2). The metes and bounds of the claim are unclear because it recites the cross-linker can comprise 2 to 6 carboxylic acids, but also requires the cross-linker be a dicarboxylic acid (hence, n=2). Appropriate correction is required. All claims that depend from claim 1 are included in this rejection. Claims 14-16 are included in this rejection because they require the support recited in claim 1. For the purpose of examination, any cross-linker with 2 to 6 groups is interpreted to read on the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 8, 14-16, 18-19 and 21-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kuebelbeck et al. (previously cited; E-polylysine conjugates and the use thereof. WO2011009539 27 January 2011) in view of Wellings et al. (Solid Support. WO2008/012064, 31 January 2008) as evidenced by Chem Europe Encyclopedia (dicarboxylic acids) and Uptima (Carbodiimides (EDAC, DCC, DIC) 2022. Pages 1-5).
Kuebelbeck et al. teach ε(epsilon)-polylysine conjugates, in particular conjugates of ε-polylysine with compounds carrying carboxyl groups (page 1, line 46). ε-polylysine is a homopolymer (hence, a polymer; page 23, line 23). As evidenced by the PG Pub of the instant application ([0003]), ε-polylysine (referred to as poly-ε-lysine in the specification) comprises chains between the amide bonds.
Kuebelbeck teaches the following regarding the compound carrying the carboxyl groups (page 10, lines 15-32):
The compound carrying carboxyl groups preferably contains two or more carboxyl groups. Examples of compounds carrying carboxyl groups which are suitable in accordance with the invention are: citric acid, succinic acid, fumaric acid, maleic acid, glutaric acid, adipic acid, tartaric acid, oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, suberic acid, azelaic acid, sebacic acid, the corresponding branched fatty acids, maleic acid, fumaric acid,
cyclohexanedicarboxylic acid and the corresponding position isomers and similar aliphatic dibasic acids; tetrahydrophthalic acid, 5-norbornene-2,3-dicarboxylic acid and similar alicyclic dibasic acids; tricarbal lytic acid, aconitic acid, trimesic acid and similar tribasic acids; adamantanetetracarboxylic acid, butanetetracarboxylic acid, cyclopentanetetra carboxylic acid, tetrahydrofurantetracarboxylic acid and similar tetrabasic acids; Sugar acids, in particular aldaric
acids, such as, for example, glucaric acid, galactaric acid; malic acid, tartaric acid, citric acid and similar hydroxy-fatty acids; trimellitic acid, pyromellitic acid, biphenyltetracarboxylic acid, benzophenonetetracarboxylic acid, diphenylSulfonetetracarboxylic acid and similar aromatic polycarboxylic acids.
As evidenced by the specification, sebacic acid and azelaic acid are dicarboxylic acids ([0030]). It is well known in the art that citric acid comprises three carboxylic acid.
As evidenced by Chem Europe Encyclopedia, oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, suberic acid are dicarboxylic acids. Cyclohexanedicarboxylic acid and 5-norbornene-2,3-dicarboxylic acid are dicarboxylic acids since they recite “dicarboxylic acid” in their names. Therefore Kuebelbeck teaches carboxylic where n=2-6.
Kuebelbeck teaches ε-polylysine is reacted with compounds carrying carboxyl groups in solution (see page 29, lines 21-25). One or more carboxyl groups of the compound carrying the carboxyl groups can be activated using a coupling reagent, such as dicyclohexylcarbodiimide, and reacted with the ε-polylysine (see page 29, lines 21-25). Kuebelbeck teaches the carboxyl group reacts with a free amino group of ε-polylysine (same cited section). As evidenced by Uptima, carbodiimides are chemical reagents used to conjugate molecules together by a covalent bond between carboxyl and amine groups (page 1, general considerations). As evidenced by Uptima, dicyclohexylcarbodiimide is a carbodiimide. The specification discloses cross-linking of poly-ε-lysine forms insoluble polymeric supports ([0004]). Therefore the polymer in particulate form would be insoluble in water.
Kuebelbeck teaches ε-polylysine is an oligomer with linked monomer units. The monomer units can be functionalized (page 19, lines 13-25). The oligomer can comprise monomer units which are derviatised. These are monomer units in which functionalities are bonded to the NH group or the amino group (page 22, lines 5-10). If the conjugate comprises a derivatized ε-polylysine unit a solid phase synthesis is used for preparation (page 30, lines 10-15). The monomer unit can contain a solid phase (page 21, line 26). Monomer units of this type can have an NH2 functional group (page 21, line 28). The art teaches a particulate material, such as nanoparticles or metal particles, is a solid phase (see page 14, lines 10-12).
Kuebelbeck teaches a solid support. The art does not teach a hollow support.
The art does not explicitly teach the polymer is functionalized with an organic synthesis initiator species.
Wellings teaches a solid support (Abstract). The art teaches a bead with a hole(s) in or through it (Abstract, page 4, lines 15-20). A bead with a hole(s) is broadly interpreted to be hollow. A polymer is disposed within the hole (Abstract; page 4, lines 15-16). The hole can be lined with polymer (page 5, lines 1-2). The polymer can be bound to the bead (page 6, limes 10-11). The solid support is used to immobilize polymers (page 10, lines 5-6). The polymer can be any suitable material (page 7, lines 1). The polymer can be reacted with a compound having at least two functional groups, one for reacting with the polymer and the other to provide free functionality for use in a desired application (page 7, lines 10-14). A functional material may be supported by the polymer. Examples of suitable functional materials include an initiator species for organic synthesis, for example peptide synthesis (page 7, line 31 bridging line 1 of page 8). Amine functionalised supports are suitable for use in peptide synthesis, oligonucleotide synthesis and solid phase organic chemistry. (page 7, lines 17-18). The solid support is useful for solid phase synthesis, particularly macromolecules (page 9, lines 31-32).
It would have been obvious to use a dicarboxylic acid to make the conjugate taught by Kuebelbeck. Kuebelbeck teaches di-carboxylic acids acid can be used to prepare the conjugate. KSR Rationale E indicates that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and commonsense” (MPEP 2143 “Rationale E. Obvious to Try” section). Kuebelbeck teaches at least one carboxyl group can be activated to react with a ε-polylysine. The skilled artisan would choose a compound with two carboxyl groups to react both carboxyl groups with a ε-polylysine. As evidenced by the PG Pub of the Instant Specification, reaction of a solution of poly-ε-lysine, carboxyl functional cross-linker and a carbodiimide results in polymerization ([0049]). Kuebelbeck reacts ε-polylysine, a carbodiimide and a carboxyl functional cross-linker in a solvent. Kuebelbeck teaches the use of dicarboxylic acids that read on the claims. Because Kuebelbeck teaches the same method, it would be expected to produce a crosslinked polymer that meets the limitations of claim 1.
It would have been obvious to immobilize the cross-linked poly-e-lysine polymer taught by Kuebelbeck on the hollow particle taught by Wellings. One would have been motivated to do so to functionalize the polymer with a solid support. One would have had a reasonable expectation of success since Kuebelbeck teaches the polymer can be functionalized with a solid support and Wellings teaches the hollow particle can support a polymer.
It would have been obvious to functionalize the polymer taught by Kuebelbeck as claimed. Kuebelbeck teaches lysine monomer units can be derivatized by solid phase protein synthesis. Wellings teaches functionalizing a polymer with an initiator species for organic synthesis, for example peptide synthesis. The skilled artisan would functionalize the polymer with an initiator species to synthesize poly-e-lysine with derivatized units. One would have had a reasonable expectation of success since
Kuebelbeck teaches NH2 functional groups and Wellings teaches amine functionalised supports are suitable for use in peptide synthesis. Therefore claim 1 is rendered obvious as claimed.
Wellings teaches the beads are spherical or ellipsoidal (page 5, line 1). Therefore claim 8 is included in this rejection.
Claim 1 is rejected on the grounds set forth above. Claim 14 recites a wound treatment product comprising a particulate support according to claim 1, and a component or a composition “for treating a wound and/or a therapeutic agent”. Claim 14 is a product, and not a method of treatment. Kuebelbeck teaches antibiotics can be bonded to the conjugate (page 40, lines 14-15). An antibiotic reads on “a therapeutic agent”. Therefore a conjugate comprising an antibiotic would be expected to function as a wound treatment product. Therefore claim 14 is included in this rejection.
Claim 15 is drawn to a medical diagnostic comprising a particulate support according to claim 1 and a functional material bound or retained by the support. A particulate support as recited in claim 1 is rendered obvious. Kuebelbeck teaches antibiotics can be bonded to the conjugate (page 40, lines 14-15). An antibiotic reads on “a functional material”. The phrase “or retained by” is interpreted to mean the functional material does not need to be in direct contact with the support. Therefore an antibiotic bonded to a conjugate would read on this limitation. Therefore claim 15 is included in this rejection.
Wellings teaches the support can be functionalized with enzymes (Abstract; page 8, line 2; page 10, line 7). Claim 16 is rendered obvious.
Kuebelbeck teaches the dicarboxylic acid can be sebacic acid. As evidenced by the specification, sebaic acid is hydrophobic (PG Pub [0029]). Therefore these compounds would have the properties recited in claims 18-19 and 22.
Regarding independent claim 21: the claim encompasses the limitations recited in claim 1. Therefore claim 21 is rejected on the same grounds.
An initiator species for peptide synthesis is rendered obvious on the grounds recited in the rejection of claim 1. Therefore claim 23 is included in this rejection.
Kuebelbeck teaches di-carboxylic acids (supra). Therefore claim 24 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
RESPONSE APPLICANT’S ARGUMENTS
The arguments made in the response filed on 02 February 2026 acknowledged. The arguments state Kuebelbeck does not teach the claimed hollow particles. New grounds of rejection have been made to address the amended claims.
CONCLUSION
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653