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 .
DETAILED ACTION
Pursuant to a preliminary amendment filed September 22, 2022, claims 1-12, 14-17 and 19-22 are currently pending in the instant application.
Response to Election/Restriction
Applicant's election without traverse of Group II, claims 9-12 and 14-16, directed to a method for studying or identifying a biologically active agent that binds to a membrane protein; and Applicant’s election of Species without traverse as follows:
Species (A): wherein the structure of the amphiphilic coating such as encompassed by claims 1, 9 and 17 comprises chitosan and the hydrophilic chemical structure at the surface of the non-porous solid support (See; pg. 10, lines 12-13 of the as-filed Specification, wherein the coating is an aminopolysaccharide, and the hydrophilic chemical structure is chitosan) (claim 9);
Species (B): further comprising at least one hydroxyl group (claim 2);
Species (C): wherein the lipophilic group comprises an alkyl chain of 4-20 carbon atoms (claim 6);
Species (D): wherein the solid support comprises a linker between the coating on the surface of the solid support and an amino group (claim 10);
Species (E): further comprising a droplet that covers a predetermined discrete spotting zone (claim 20), in the reply filed December 5, 2025 is acknowledged.
Claims 1-8, 17 and 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 15 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement is still deemed proper and is therefore made FINAL.
Please Note: claim 9 refers back to withdrawn claim 1, such that independent claim 9 does not recite a structure for the non-porous solid support comprising a planar surface coated with an amphiphilic coating.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 9-12 and 14 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed September 22, 2022, is a 35 U.S.C. 371 national stage filing of
International Application No. PCT/EP2021/057520, filed March 24, 2021, which claims the benefit of German Patent Application DE 10-2020-108-373.4, filed March 26, 2020.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Germany on March 26, 2020 including the certified copy of the German Patent Application 10-2020-108-373.4 as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on September 22, 2022 and September 23, 2025 have been considered. Initialed copies of the IDSs accompany this Office Action.
Claim Objections/Rejections
Claim Interpretation: the product of claim 9 is interpreted to comprise a planar surface coated with an amphiphilic coating.
Claim Objection
Claims 11, 12 and 14 are objected to because of the following informalities: Claims 11, 12 and 14 recite a mixture of pronouns including “the” and “said” within each claim, such that for consistency, a single pronoun reciting either “the” or “said” should be used.
Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recite the term “Boe,” where an abbreviation should be spelled out in the first encounter of the claims.
Appropriate correction is required.
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.
Claims 9-12 and 14 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 applicant regards as the invention.
Claim 9 is indefinite for the recitation of the term “an amphiphilic coating of claim 1” such as recited in claim 9, line 2 because claim 9 refers back to withdrawn claim 1, such that the structure of the amphiphilic coating is unclear with respect to instant claim 9 and, thus, the metes and bounds of the claim cannot be determined.
Claims 10-12 and 14 are indefinite for the recitation of the term “the solid support” such as recited in claim 10, lines 4-6. There is insufficient antecedent basis for the term “the solid support” in the claim because claim 9, line 1 recites the term “a non-porous solid support.” Moreover, claim 10 depends from instant claim 9, wherein the term “solid support” is recited in the preamble of claim 9, such that the term “solid support” is not recited in the body of the claim. Thus, the term “solid support” was not accorded any patentable weight, and the product of claim 9 is not interpreted to comprise a solid support and, thus, the metes and bounds of the claim cannot be determined.
Claim 10 is indefinite for the recitation of the term “the surface” such as recited in claim 10, line 5. There is insufficient antecedent basis for the term “the surface” in the claim because claim 9, line 1 recites the term “a planar surface.”
Claim 11 is indefinite for the recitation of the term “preferably" in reference to the “formula (aa)n” in claim 11, line 2 because a broad range or limitation is together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. Examples and preferences lead to confusion over the intended scope of the claim, where it is not clear whether the claimed narrower range is a limitation.
Claim 11 is indefinite for the recitation of the term “the formula (aa)n” such as recited in claim 11, line 2. There is insufficient antecedent basis for the term “the formula (aa)n” in the claim.
Claim 11 is indefinite for the recitation of the term “in the range of 3 to 10” such as recited in claim 11, line 3 because a broad range or limitation is together with a narrow range of limitation that falls within the broad range or limitation (in the same claim) is considered indefinite since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The term “in the range of 3 to 10” does not set forth any specific limitation as to the integer value, but encompasses an estimate or approximation of a beginning value and of an end value and, thus, the metes and bounds of the claim cannot be determined.
Claim 14 is indefinite for the recitation of the term “said side chain protected amino acid aa” such as recited in claim 14, lines 1-2. There is insufficient antecedent basis for the term “said side chain protected amino acid aa” in the claim because claim 11, lines 2-3 recites the term “aa is an amino acid or a protected amino acid” and claim 12, lines 3-4 recites the term “said amino acids lysine, serine…are side chain protected.”
Claim 14 is indefinite for the recitation of the term “is protected with a protection group selected from tBu (tert-Butyl) protected serine…and Boe protected lysine” such as recited in claim 14, lines 2-4 because the term “protected with a protection group selected from…” refers to the protection group and not to a selection of protected amino acids, such that the list is confusing and, thus, the metes and bounds of the claim cannot be determined. The Examiner suggests that Applicant amend the claim to recite, for example: “the protected amino acids of the poly-amino acid linker are selected from the group consisting of tert-butyl (t-Bu) protected serine…and Boe protected lysine” OR “the protected amino acids comprise a protecting group selected from the group consisting of tert-butyl (t-Bu), fluoro-methoxy carbonyl (Fmoc), and tert-butoxycarbonyl (Boc)” (if applicable).
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 10 is rejected under 35 U.S.C. 112(d) 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 10 recites (in part): “the solid support includes a linker between the amphiphilic coating on the surface of the solid support and an amino groups” such as recited in claim 10, lines 4-6 because claim 10 depends from instant claim 9, wherein claim 9 does not recite a product comprising a “solid support” and/or a surface thereof. Thus, claim 10 is an improper dependent claim 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.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 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.
Claims 9-12 and 14 are rejected under 35 U.S.C. 102(a1)/102(a2) as being anticipated by Sundberg et al. (hereinafter “Sundberg”) (US Patent No. 5624711, issued April 29, 1997).
Regarding claims 9 and 10, Sundberg teaches that methods providing means to control the functional site density on a solid support, wherein some of the derivatized supports are polymer coated or glycan-coated; as well as, other methods for regenerating the surface of a used ligand array are also provided (interpreted as coating a solid support, claim 9) (Abstract). Sundberg teaches sets of monomers for the synthesis of polypeptides, wherein each of the sets of monomers can include protected members which are modified after synthesis for the preparation of molecules containing sequences of monomers including amino acids or other polymers such as polysaccharides, phospholipids, and peptides having either a-, b- or g-amino acids, heteropolymers in which a known drug is covalently bound to any of the above, polynucleotides, polyesters, polyamides, etc. (interpreted as polysaccharides; amphiphilic coatings; and protected amino acids, claims 9 and 10) (col 5, lines 3-13). Sundberg teaches that Figure 1 illustrates the "doped process" of derivatizing a solid support such as a glass slide is cleaned and derivatized with an aminoalkylsilane to provide a surface of amine functional groups, such that treatment of this derivatized substrate with a mixture of linking molecules (e.g., NVOC-aminocaproic acid) and diluent molecules (e.g., protected amino acids) provides a surface having synthesis initiation sites at a preselected density, wherein the density of synthesis initiation sites will depend on the particular ratio of linking molecules to diluent molecules used (interpreting a glass slide as a planar surface having an amino group for subsequent array synthesis; NVOC-aminocaproic acid as a lipophilic group; interpreting diluent molecules as amino acid linkers including protected amino acid linkers having the structure (aa)n; and interpreting amino acids and alkyl silyl groups as comprising hydrophilic structure, lipophilic group, and a hydroxyl, claims 9 and 10) (col 11, lines 7-19; and Figure 1). Sundberg teaches that groups which are suitable for attachment to a linking molecule or diluent molecule include amine, hydroxyl, thiol, carboxylic acid, ester, amide, epoxide, isocyanate and isothiocyanate, wherein the derivatization reagents can have a protecting group attached to the reactive site on the distal or terminal end of the derivatization reagent (opposite the solid substrate), wherein derivatization reagents include aminoalkyltrialkoxysilanes, amino-alkyltrichlorosilanes, hydroxyalkyltrialkoxysilanes, hydroxyalkyltrichlorosilanes, carboxyalkyltrialkoxy-silanes, polyethyleneglycols, epoxyalkyltrialkoxysilanes, and combinations thereof (interpreted as producing an amphiphilic coating comprising at least one hydrophilic structure; at least one lipophilic group; and including at least one hydroxyl group, claims 9 and 10) (col 11, lines 7-19). Sundberg teaches that the linking molecule contributes to the net hydrophobic or hydrophilic nature of the surface including a hydrocarbon chain, such as --(CH2)n--, the effect is to decrease wettability, wherein linking molecules including polyoxyethylene (--(CH2CH2O)n-), or polyamide (--(CH2CONH)n-) chains tend to make the surface more hydrophilic (i.e., increase wettability) (interpreting polysaccharides, phospholipids, peptides and polyoxyethylene linking groups as forming an amphiphilic coating comprising at least one hydrophilic structure; at least one lipophilic group; and including at least one hydroxyl group, claims 9 and 10) (col 12, lines 47-53).
Regarding claim 11, Sundberg teaches that the linking molecules used in the present invention are of sufficient length to permit any polymers synthesized thereon to interact freely with molecules exposed to the polymers, wherein the linking molecules should be 3-50 atoms long to provide sufficient exposure of ligands to their receptors, such that the linking molecules will typically be aryl acetylene, ethylene glycol oligomers containing 2-14 monomer units, diamines, diacids, amino acids, peptides, or combinations thereof (interpreted as a (poly)amino acid linker having a formula (aa)n; and encompassing 3-10 amino acids, claim 11) (col 12, lines 21-29).
Regarding claim 12, Sundberg teaches sets of monomers for the synthesis of polypeptides, wherein each of the sets of monomers can include protected members which are modified after synthesis for the preparation of molecules containing sequences of monomers including amino acids or other polymers such as polysaccharides, phospholipids, and peptides having either a-, b- or g-amino acids, heteropolymers in which a known drug is covalently bound to any of the above, polynucleotides, polyesters, polyamides, etc. (interpreted as polysaccharides; amphiphilic coatings; and protected amino acids, claim 9) (col 5, lines 3-13). Sundberg teaches that Figure 1 illustrates the "doped process" of derivatizing a solid support such as a glass slide is cleaned and derivatized with an aminoalkylsilane to provide a surface of amine functional groups, such that treatment of this derivatized substrate with a mixture of linking molecules (e.g., NVOC-aminocaproic acid) and diluent molecules (e.g., protected amino acids) provides a surface having synthesis initiation sites at a preselected density, wherein the density of synthesis initiation sites will depend on the particular ratio of linking molecules to diluent molecules used (interpreting a glass slide as a planar surface having amino groups; and interpreting diluent molecules as amino acid linkers including protected amino acid linkers having the structure (aa)n, claims 9-11) (col 11, lines 7-19; and Figure 1). Sundberg teaches that protecting groups of the invention are selected so as to be selectively removable, wherein other suitable protecting groups include FMOC, DMT, NVOC, MeNPOC, BOC and ALLOC (interpreted as protecting groups, claims 11 and 12) (col 13, lines 13-16).
Regarding claim 14, Sundberg teaches the use of O-t-Butyl serine as a diluent molecule provides a hydrophobic surface during polymer synthesis, but upon treatment with acid (cleaving the t-butyl ether), a more hydrophilic surface is produced for assays, such that after reacting the mixture of linking molecules and diluent molecules with the surface and subsequently synthesizing a desired polymer onto the functional sites on the linking group, the protecting groups on the surface-attached diluent molecules are removed to provide a more hydrophilic (i.e. "wettable") surface, wherein the diluent molecules preferably include protected glycine, protected serine, glutamic acid, or protected lysine (interpreted as encompassing protected lysine, serine, threonine, aspartic acid, and glutamic acid; and t-Bu protecting groups, claim 14) (col 13, lines 1-12).
Sundberg meets all the limitations of the claims and, therefore, anticipates the claimed invention.
Conclusion
Claims 9-12 and 14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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, Heather Calamita can be reached on (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY M BUNKER/Primary Examiner, Art Unit 1684