DETAILED ACTION
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
Applicant's election with traverse of Group I, presently claims 1-10 and 16, in the reply filed on 8/14/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious search burden on the examiner to search all the claims. This is not found persuasive because search burden is not a consideration in finding of lack of inventive unity; rather, according to M.P.E.P. §1850, the only consideration is whether the inventions share a special technical feature and none of Applicant’s arguments at this time persuasively set forth that the different groups of inventions as set forth in the Restriction requirement dated 7/22/2026 possess unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/14/2026.
Claims 1-10 and 16 are under consideration on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that 1) SEQ ID NO: 10 is recited in the specification (e.g. Table 2), but is blank in the originally filed XML sequence listing, and 2) SEQ ID NOs: 80, 139, and 225 have no sequence information. These sequences are only generally alluded to in the specification at [0045] as part of SEQ ID NOs: 4-344, and the respective entries for these sequences in the originally filed XML sequence listing are blank.
A corrected sequence listing is required Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claim 3 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.
Claim 3 is in improper Markush form; a Markush group should be in the form “an agent selected from the group consisting of A, B, and C” or “wherein the agent is A, B, or C”. Currently, it is not clear which species are included in the Markush group and which are not. Correction is required.
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.
Claims 1, 4-8, 10, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiduwild et al. (Adv. Mater. (2018), 30, 1706100, 9 pages; provided in the IDS dated 9/23/2024).
Weiduwild teaches a multilayer scaffold composition deposited on a generic substrate/article for culturing mesenchymal stem cells, comprising a first layer comprising chondroitin sulfate and KA7-RGDSP-starPEG and a second layer comprising heparin and KA7-RGDSP-starPEG (the paragraph starting “Encouraged by the facile synthesis…” page 3 which continues on page 5, and Figure 3; page 3, the paragraph starting “Thin layer formation and…” for “chondroitin” being used synonymously by Weiduwild for chondroitin sulfate), anticipating claims 1 and 6, the embodiments of (YZ)n and n = 1 for claim 4, the embodiment of (ZY)n and n = 1 for claim 5, the embodiment of chondroitin sulfate for the sulfated oligosaccharide of claim 7, the embodiments of a = 7, starPEG, and RGDSP reading on SEQ ID NO: 4 for claim 8, mesenchymal stem cells for claim 10, and the embodiments of heparin and chondroitin sulfate for claim 16.
Claims 1, 2, 4-7, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aggarwal et al. (Colloids and Surfaces B: Biointerfaces (2014), 116, 93-103; Reference U).
Aggarwal teaches a multilayer scaffold composition deposited on glass slides for culturing C2C12 myoblast (mouse) cells, comprising polycationic chitosan and either sulfated cellulose or heparin (Abstract; subheading 2.6.2) and having 7 or 8 layers (Table 2), anticipating claims 1, the embodiments of (YZ)n and n = 8 for claim 4, the embodiment of (ZY)n and n = 8 for claim 5, claim 6 (i.e. the multilayering inherently yields a 3D structure), the embodiment of sulfated cellulose for claim 7, and the embodiment of heparin for claim 16. Aggarwal teaches zeta potentials (i.e. surface charge) decreases from about 60 mV to either -60 mV with a terminal chitosan layer (Fig. 4B) or to -100 mV with a terminal polyanion layer (Fig. 4C) as a function of increasing pH, anticipating claim 2.
Regarding the preamble of claim 1, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See M.P.E.P. § 2111.02 and 2111.04. In the instant case, claim 1 recites a structurally complete composition of matter coated on a generic article. Therefore, the preamble does not further limit the structure of the claimed composition and coated article as such as statement amounts to an intended use, and is afforded no patentable weight. Alternatively, because Aggarwal teaches every structural limitation of claim 1 and that the coated glass slides are capable of culturing mammalian C2C12 cells as cited above, Aggarwal is reasonably presumed capable of meeting the intended outcome of the preamble of claim 1 absent any showing to the contrary. See M.P.E.P. § 2112.
Claim Rejections - 35 USC § 103
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4-10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Weiduwild et al. (Adv. Mater. (2018), 30, 1706100, 9 pages; provided in the IDS dated 9/23/2024) in view of Zhang et al. (EP3415165A1; provided in the IDS dated 9/23/2024).
The teachings of Weiduwild are relied upon as set forth above in rejecting claims 1, 4-8, 10, and 16 as anticipated under 35 U.S.C. § 102(a)(1).
Regarding claim 3, Weiduwild does not teach the embodiment of polystyrene sulfate (PSS) or sulfated alginate. Regarding claim 9, Weiduwild does not teach the embodiment of poly-D-lysine as a primer layer. Alternatively regarding claim 16, Weiduwild does not teach heparin sulfate, dermatan sulfate, keratan sulfate, or dextran sulfate.
Zhang teaches a biomatrix layer comprising sulfated oligosaccharide and a peptide-PEG conjugate (Abstract). Zhang teaches heparin, heparan sulfate, chondroitin sulfate, dermatan sulfate, keratan sulfate, dextran sulfate, polystyrene sulfate (PSS), and sulfated alginate as exemplary species of negatively charged polysaccharides (NCP) (claim 6), reading on claim 3 and alternatively reading on claim 16. Zhang teaches poly-D-lysine (as a primer layer) for culturing human mesenchymal stromal/stem cells (hMSCs) prior to culturing the hMSCs with the biomatrix layer ([0161]-[0162]; also [0112] for MSCs), reading on claim 9. Zhang teaches an exemplary peptide-PEG conjugate comprising KA7-RGDSP-starPEG ([0162], wherein “KA” is alternating sequences of Lysine-Alanine and “7” is the number of KA repeats), reading in-part on claims 3 and 9. Zhang teaches a multilayer biomatrix comprising a first and second layer deposited on a generic substrate/article ([0112] and [0146]), reading in-part on claims 3 and 9.
Regarding claim 3 and alternatively regarding claim 16, a person of ordinary skill in the art would have had a reasonable expectation of success in substituting the polystyrene sulfate (PSS), sulfated alginate, heparin sulfate, dermatan sulfate, keratan sulfate, or dextran sulfate of Zhang for the heparin or chondroitin sulfate of Weiduwild because all of the species of polysaccharides are explicitly taught as being useful for THE SAME PURPOSE as negatively charged polysaccharides in multilayered composition and coated articles therein for cell culture. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Regarding claim 9, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the poly-D-lysine of Zhang to Weiduwild’s multilayered composition and coated articles therein for cell culture. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Weiduwild and Zhang are directed towards multilayered compositions comprising negatively charged polysaccharides and a positively charged conjugate (i.e. the KA7 conjugate) and coated articles therein for cell culture and are both directed towards mesenchymal stem cells. The skilled artisan would have been motivated to do so because Zhang teaches that poly-D-lysine (as a primer layer) for culturing human mesenchymal stromal/stem cells (hMSCs)) prior to culturing the hMSCs with the biomatrix layer, and so the addition would predictably improve the utility of Weiduwild’s coated article for downstream methods of culturing mesenchymal stem cells.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1-7, 9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Aggarwal et al. (Colloids and Surfaces B: Biointerfaces (2014), 116, 93-103; Reference U) in view of Zhang et al. (EP3415165A1; provided in the IDS dated 9/23/2024).
The teachings of Aggarwal are relied upon as set forth above in rejecting claims 1, 2, 4-7, and 16 as anticipated under 35 U.S.C. § 102(a)(1).
Regarding claim 3, Aggarwal does not teach the embodiment of polystyrene sulfate (PSS) or sulfated alginate. Regarding claim 9, Aggarwal does not teach the embodiment of poly-D-lysine as a primer layer. Alternatively regarding claim 16, Aggarwal does not teach heparin sulfate, dermatan sulfate, keratan sulfate, or dextran sulfate.
Zhang teaches a biomatrix layer comprising sulfated oligosaccharide and a peptide-PEG conjugate (Abstract). Zhang teaches heparin, heparan sulfate, chondroitin sulfate, dermatan sulfate, keratan sulfate, dextran sulfate, polystyrene sulfate (PSS), and sulfated alginate as exemplary species of negatively charged polysaccharides (NCP) (claim 6), reading on claim 3 and alternatively reading on claim 16. Zhang teaches poly-D-lysine (as a primer layer) for culturing human mesenchymal stromal/stem cells (hMSCs)) prior to culturing the hMSCs with the biomatrix layer ([0161]-[0162]; also [0112] for MSCs), reading on claim 9. Zhang teaches an exemplary peptide-PEG conjugate comprising KA7-RGDSP-starPEG ([0162], wherein “KA” is alternating sequences of Lysine-Alanine and “7” is the number of KA repeats), reading in-part on claims 3 and 9. Zhang teaches a multilayer biomatrix comprising a first and second layer deposited on a generic substrate/article ([0112] and [0146]), reading in-part on claims 3 and 9.
Regarding claim 3 and alternatively regarding claim 16, a person of ordinary skill in the art would have had a reasonable expectation of success in substituting the polystyrene sulfate (PSS), sulfated alginate, heparin sulfate, dermatan sulfate, keratan sulfate, or dextran sulfate of Zhang for the heparin or sulfated cellulose of Aggarwal because all of the species of polysaccharides are explicitly taught as being useful for THE SAME PURPOSE as negatively charged polysaccharides in multilayered composition and coated articles therein for cell culture. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Regarding claim 9, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the poly-D-lysine of Zhang to Aggarwal’s multilayered composition and coated articles therein for cell culture. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Aggarwal and Zhang are directed towards multilayered compositions comprising negatively charged polysaccharides and a positively charged conjugate (i.e. the KA7 conjugate) and coated articles therein for cell culture and are both directed towards culturing mammalian cells. The skilled artisan would have been motivated to do so because Zhang teaches that poly-D-lysine (as a primer layer) for culturing human mesenchymal stromal/stem cells (hMSCs)) prior to culturing the hMSCs with the biomatrix layer, and so the addition would predictably improve the utility of Aggarwal’s coated article for downstream methods of culturing mammalian cells.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 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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/Sean C. Barron/Primary Examiner, Art Unit 1653
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