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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/03/2026 has been entered.
Claims 1 and 2 have been amended. No claims have been canceled or newly added.
Claims 1-20 are currently pending.
Claims 9 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/10/2025.
Claims 1-8, 10-15 and 17-20 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies have been filed in the current application on 11/01/2021.
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.
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.
Claim(s) 1-2, 7-8, 14-15, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Haneda et al (WO 2019/131978-machine translation) in view of Lee et al (Biomaterials 1994-newly cited).
Regarding claims 1-2, 7-8 and 14-15, Haneda ‘978 disclose a scaffolding material that contains a polyvinyl alcohol derivative with an amount of hydroxyl groups that of 28 mol% (page 16 example 1) (which falls within the amounts of hydroxyl groups disclosed by Applicant’s Specification at pages 16-17 paragraph 47, and thus provides a hydroxyl value of 1,100 mg KOH/g or less). Haneda ‘978 also disclose that suitable polymers include polyvinyl alcohol and polypeptide and combinations thereof which have been chemically bonded (page 5). Crosslinking of the scaffold material is also disclosed (page 15) and the crosslinking of a polyvinyl alcohol polymer with a polypeptide polymer would provide a peptide-conjugated polyvinyl alcohol derivative. This renders obvious the technical feature of peptide-conjugated polyvinyl alcohol derivative with a hydroxyl value of 1,100 mg KOH/g or less. Haneda also disclose that their scaffolding material includes a polyvinyl alcohol derivative with an acetal resin portion (pages 4-6) bonded by linker portion (page 9).
Haneda also suggest that additional polymers include aromatic carboxylic acids as well as polypeptide polymers (page 5).
While Haneda do not specifically describe the claimed acid values or claimed peptide content, they are drawn to the enhancement of cell adhesion and cell proliferation and thus would have arrived at the claimed acid values and claimed peptide content through routine optimization and experimentation.
The specific combination of features claimed is disclosed within the broad genera of polymer types, type of polyvinyl alcohol derivative, types of bonds and amounts of hydroxyl groups taught by Haneda, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen 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”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of polymer types, type of polyvinyl alcohol derivative, types of bonds and amounts of hydroxyl groups from within the disclosure of Haneda to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
The motivation and reasonable expectation of success in making these combinations comes from the fact that Haneda ‘978 suggests that all these cited variables are suitable for inclusion in their method/composition.
In addition, Lee disclose that it is recognized that the adhesion and proliferation of different cell types on polymeric materials depend on surface characteristics such as wettability (hydrophilicity/hydrophobicity or surface free energy), chemistry, charge, roughness and rigidity (page 705, column 1). Hydroxyl groups and carboxylic acid groups are disclosed as affecting cell adhesion, spreading and growth (abstract, pages 707-708 results and discussion, (pages 709-710 cell adhesion and growth on functional group-grafted surfaces).
Therefore, one of ordinary skill in the art would have been motivated to optimize the acid value of the polymer scaffolds produced by Haneda because Lee suggest that this value has an effect on cell adhesion, spreading and growth on substrate surfaces. One skilled in the art would recognize acid value as an indicator of free acid groups present and would optimize accordingly to achieve cell adhesion, spreading and growth within the desired range. A mildly acidic or neutral pH would be desired for cell therapy while an acidic pH would be suitable for a disease model.
Regarding claims 19-20, the cited prior art does not expressly disclose the claimed ratio of the peptide portion in the peptide-conjugated polyvinyl alcohol derivative. Nevertheless, the obviousness analysis may “take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). For example, the analysis may “include recourse to logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference or expert opinion.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009). The Patent Trial and Appeal Board has held that mixing equivalent components in a 1:1 ratio represented no more than application of the “logic, judgment, and common sense available to the person of ordinary skill” in the art. Ex parte Swanzy, Appeal 2017-004875 at 8-9.
In this case, Haneda discloses polypeptides and aromatic carboxylic acids as equally suitable alternatives to one another and therefore recognizes the equivalence of the two. It would have been prima facie obvious, using no more than ordinary creativity, logic, judgment, and common sense, to combine polypeptides and aromatic carboxylic acids in equal amounts (i.e. in a 1:1 ratio) based on the fact that both are disclosed in parallel as being equally suitable for use in this capacity. This 1:1 ratio falls within the claimed ratio.
Therefore, the combined teachings of Haneda ‘978 and Lee et al render obvious Applicant’s invention as claimed.
Claim(s) 3-6 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Haneda et al (WO 2019/131978-machine translation) in view of Lee et al (Biomaterials 1994-newly cited) as applied to claims 1-2, 7-8, 14-15, 19-20 above, and further in view of KR 100790764.
Regarding claims 3-6 and 10-13, Haneda and Lee render obvious a cell scaffold as described above, but do not specifically disclose including a cell adhesive peptide portion with an amino acid sequence in their scaffold.
KR 100790764 disclose methods of using polypeptides to augment a population of hematopoietic cells, including hematopoietic stem cells, to a matrix (page 3). The use of RGD amino acid sequence Arg-Gly-Asp-X wherein X is a serine with the matrix provides and retains cell binding activity to a protein matrix (bottom of page 6 to top of page 7).
One of ordinary skill in the art would have been motivated to include RGD with an amino acid sequence Arg-Gly-Asp-X wherein X is a serine with the polypeptide polymer matrix of Haneda because KR 100790764 disclose that this will provide and retain cell binding of hematopoietic stem cells to a protein matrix. One of ordinary skill in the art would have had a reasonable expectation of success because Haneda and KR 100790764 are both drawn to the binding of stem cells, specifically hematopoietic stem cells (Haneda page 3 of machine translation), to a polypeptide polymer matrix.
Therefore, the combined teachings of Haneda et al, Lee et al and KR 100790764 render obvious Applicant’s invention as claimed.
Claim(s) 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Haneda et al (WO 2019/131978-machine translation) in view of Lee et al (Biomaterials 1994-newly cited) as applied to claims 1-2, 7-8, 14-15, 19-20 above, and further in view of Hiraguchi (Thesis of the University of Tokyo, 2018-from IDS filed 07/17/2025).
Regarding claims 17-18, Haneda and Lee render obvious a cell scaffold as described above, but do not specifically disclose including a sea-island structure.
Hiraguchi disclose the manufacture of cell culture scaffolds using polyvinyl acetyl resin and that simple phase reversal of the distribution of adsorbed proteins can be used to affect cell adhesion behaviors for designing biomaterial surfaces, including a sea-island structure (dot-like domains), for tissue engineering applications (abstract, page 2992, Figure 1, page 2994).
One of ordinary skill in the art would have been motivated to include a sea-island structure in the Haneda scaffold method because Hiraguchi teach and suggest that this provides a beneficial control of cell adhesion for tissue engineering applications. One of ordinary skill in the art would have had a reasonable expectation of success because both Haneda and Hiraguchi include polyvinyl alcohol derivatives with an acetal resin portion for use with polypeptides as a cell scaffold.
Therefore, the combined teachings of Haneda et al, Lee et al and Hiraguchi et al render obvious Applicant’s invention as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 10-15 and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-12 of copending Application No. 17/608,062 in view of Haneda et al (WO 2019/131978-machine translation) and Lee et al (Biomaterials 1994-newly cited).
The claims of ‘062 are drawn to a cell culture scaffold material comprising a peptide-conjugated polyvinyl alcohol derivative having a polyvinyl alcohol derivative portion and a peptide portion, wherein the peptide portion has a cell adhesive amino acid sequence, such as an RGD sequence, wherein the peptide portion is composed of 4 to 10 amino acids (which overlaps and renders obvious the claimed range of 3-10 amino acids), wherein the portions are bound via linker portion, and include a polyvinyl acetal resin.
The claims of ‘062 do not recite wherein the scaffold and/or the peptide-conjugated polyvinyl alcohol derivative has a hydroxyl value of 50 mgKOH/g or more and 950 mgKOH/g or less.
Haneda ‘978 disclose a scaffolding material that contains a polyvinyl alcohol derivative with an amount of hydroxyl groups that of 28 mol% (page 16 example 1) (which falls within the amounts of hydroxyl groups disclosed by Applicant’s Specification at pages 16-17 paragraph 47, and thus provides a hydroxyl value of 1,100 mg KOH/g or less). Haneda ‘978 also disclose that suitable polymers include polyvinyl alcohol and polypeptide and combinations thereof which have been chemically bonded (page 5). Crosslinking of the scaffold material is also disclosed (page 15) and the crosslinking of a polyvinyl alcohol polymer with a polypeptide polymer would provide a peptide-conjugated polyvinyl alcohol derivative. This renders obvious the technical feature of peptide-conjugated polyvinyl alcohol derivative with a hydroxyl value of 1,100 mg KOH/g or less. Haneda also disclose that their scaffolding material includes a polyvinyl alcohol derivative with an acetal resin portion (pages 4-6) bonded by linker portion (page 9).
One of ordinary skill in the art would have been motivated to use a scaffold and/or a peptide-conjugated polyvinyl alcohol derivative with an amount of hydroxyl groups that of 28 mol% (page 16 example 1) (which falls within the amounts of hydroxyl groups disclosed by Applicant’s Specification at pages 16-17 paragraph 47, and thus provides a hydroxyl value of 1,100 mg KOH/g or less) in the scaffold matrix of the ‘062 claims because Haneda teach and suggest that this is suitable and beneficial for this type of cell scaffold matrix. One of ordinary skill in the art would have had a reasonable expectation of success because both Haneda and the ‘062 claims are drawn to cell scaffolds with a polyvinyl alcohol derivative and can be crosslinked to polypeptide polymers.
Haneda also suggest that additional polymers include aromatic carboxylic acids as well as polypeptide polymers (page 5).
While Haneda do not specifically describe the claimed acid values or claimed peptide content, they are drawn to the enhancement of cell adhesion and cell proliferation and thus would have arrived at the claimed acid values and claimed peptide content through routine optimization and experimentation.
The specific combination of features claimed is disclosed within the broad genera of polymer types, type of polyvinyl alcohol derivative, types of bonds and amounts of hydroxyl groups taught by Haneda, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
In addition, Lee disclose that it is recognized that the adhesion and proliferation of different cell types on polymeric materials depend on surface characteristics such as wettability (hydrophilicity/hydrophobicity or surface free energy), chemistry, charge, roughness and rigidity (page 705, column 1). Hydroxyl groups and carboxylic acid groups are disclosed as affecting cell adhesion, spreading and growth (abstract, pages 707-708 results and discussion, (pages 709-710 cell adhesion and growth on functional group-grafted surfaces).
Therefore, one of ordinary skill in the art would have been motivated to optimize the acid value of the polymer scaffolds produced by Haneda because Lee suggest that this value has an effect on cell adhesion, spreading and growth on substrate surfaces. One skilled in the art would recognize acid value as an indicator of free acid groups present and would optimize accordingly to achieve cell adhesion, spreading and growth within the desired range. A mildly acidic or neutral pH would be desired for cell therapy while an acidic pH would be suitable for a disease model.
Regarding claims 19-20, the cited prior art does not expressly disclose the claimed ratio of the peptide portion in the peptide-conjugated polyvinyl alcohol derivative. Nevertheless, the obviousness analysis may “take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). For example, the analysis may “include recourse to logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference or expert opinion.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009). The Patent Trial and Appeal Board has held that mixing equivalent components in a 1:1 ratio represented no more than application of the “logic, judgment, and common sense available to the person of ordinary skill” in the art. Ex parte Swanzy, Appeal 2017-004875 at 8-9.
In this case, Haneda discloses polypeptides and aromatic carboxylic acids as equally suitable alternatives to one another and therefore recognizes the equivalence of the two. It would have been prima facie obvious, using no more than ordinary creativity, logic, judgment, and common sense, to combine polypeptides and aromatic carboxylic acids in equal amounts (i.e. in a 1:1 ratio) based on the fact that both are disclosed in parallel as being equally suitable for use in this capacity. This 1:1 ratio falls within the claimed ratio.
Therefore, the combined teachings of claims ‘062, Haneda et al and Lee et al render obvious Applicant’s invention as claimed.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 04/03/2026 have been fully considered but they are not persuasive.
Applicant argues that Haneda does not include peptides or compounds having carboxyl groups in any of their examples 1-17. Applicant asserts that in all of the examples of Haneda that the acid value is 0 mgKOH/g and that this fails to overlap with the presently required acid value. Applicant asserts that nothing in Haneda motivates a person having ordinary skill in the art from limiting the hydroxyl value and the acid value within the presently specified ranges.
This is not found persuasive. Haneda specifically state that their invention is not limited to their specific examples (page 14). In addition, the obviousness rejection has been modified as described above to address the new limitations.
Applicant argues that the combination of Haneda and Singh would not have led one of ordinary skill in the art to arrive at the present claims with a reasonable expectation of success.
This is not found persuasive. The previous 103 rejection has been modified and now includes the Lee reference which provides more evidence that the optimization of surface chemistry is in fact well known in the prior art and thus obvious as described above.
Applicant argues that the claims of the copending US ‘062 application fail to teach or suggest all the limitations of the current claims even when combined with Haneda.
This is not found persuasive. The double patenting rejection has been modified and thus is not deemed to be deficient.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sung et al., “The effect of scaffold degradation rate on three-dimensional cell growth and angiogenesis”, Biomaterials, 2004, Vol. 25, pp. 5735–5742.
(Sung discloses that an acidic environment has a negative effect on cells on a scaffold.)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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