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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 29, 2025, has been entered.
Election/Restrictions
Applicant’s election of Group I (Claims 1-4, 7-9, 11-12, and 18-19; drawn to a resin film) in the reply filed on December 6, 2024, is acknowledged.
Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups II and III), there being no allowable generic or linking claim. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
DETAILED ACTION
The amended claims filed on December 29, 2025, have been acknowledged. Claims 5-6, 10, 13-14, and 17 were cancelled. Claims 1-2, 8-9, and 11 were amended. Claims 18-19 are new. In light of the Applicant’s elected invention, claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-4, 7-9, 11-12, and 18-19 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from JP2019-092083 and JP2019-119079 filed on May 15, 2019 and June 26, 2019, respectively. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received November 1, 2021. While a certified copy of the foreign patent applications JP2019-092083 and JP2019-119079 are provided with the instant application, a certified English translation of said foreign patent applications have not been provided. While a certified copy of the foreign patent application PCT/JP2020/019416, filed on May 15, 2020, is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Information Disclosure Statement
The information disclosure statement (IDS) filed on December 19, 2025, has been considered.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 2 and 10-11 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 is with drawn in light of Applicant’s amendments to claims to recite how they made their measurements and the cancellation of claim 10.
The prior rejection of claim 5 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 is withdrawn in light of the cancellation of claim 5.
Withdrawn Claim Rejections - 35 USC § 102
The prior rejection of claims 1-4 and 12 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by United States Patent No. 9938384 (Takeoka) is withdrawn in light of Applicant’s amendments to claim 1 to recite that the resin film comprises a peptide-conjugated polyvinyl acetal resin.
New 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-4, 8-9, 11-12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 9938384 (Takeoka; previous art of record) further in view of United States Patent Application No. 20090131548 (Muratoglu), United States Patent No: 4537790 (Horodniceanu), United States Patent No. 8275293 (Ono), United States Patent No. 8431947 (Ootsuki), United States Patent Application No. 20120322145 (Onofiok), and George et al. (Biomaterials 30: 4732–4737. 2009; previous art of record). This is a new rejection made in response to Applicant’s amendments to claim 1. Applicant’s traversal has been fully considered but is moot in response to the new rejection of record.
Regarding claims 1 and 3-4, Takeoka teaches a method of making a phase separated ultra-thin polymer film wherein the phase separated polymers form a sea-island structure. Furthermore, Takeoka teaches that at least one of the polymers can be polyvinyl acetate (abstract and column 3, line 14-column 8, line 20). Takeoka teaches that the film can be used for cell culture (i.e. it is a cell culture scaffold material) (column 12, lines 30-34). Regarding the ratio of the surface area of the first phase to the second phase, Takeoka teaches that the film has a size of preferably 5 cm and may be in the shape of a square (i.e. 5 cm x 5 cm), that the density of the island parts can be 1/μm2, and that the diameter of the island parts can be 0.5 μm. Under this scenario, the ratio of the first to the second phase would be .50 (column 28, line 30-column 29, line 54).
Takeoka does not teach wherein the synthetic resin is a polyvinyl acetal resin.
However, Muratoglu disclose methods of making vinyl polymer hydrogels (abstract) that can be tailored to be populated by a desired class of cells (paragraph 68). Suitable vinyl polymers include both polyvinyl acetate (PVac) and polyvinyl butyral (PVB; a polyvinyl acetal resin) (paragraph 43).
Furthermore, Horodniceanu teaches that thermosetting plastics can be applied to cell cultures to form a film and must be non-toxic to the cells and can be used for cultivation of cells. Polyvinyl butyral is identified as a suitable thermosetting plastic for coating cell cultures (column 2, line 5-column 4, line 16).
Ono teaches a film with two resins that form a sea/island structure. The “sea/island structure” refers to a structure in which at least two resins (the first resin and the second resin) are mixed in an incompatible state. That is, in the “sea/island structure”, a continuous phase containing the first resin is defined as the sea portion 33A, and a discontinuous phase that contains the second resin and is suspended in the sea portion 33A is defined as the island portion 33B.
The sea/island structure can be formed by controlling a ratio of solubility parameter (SP value) of the first resin to that of the second resin (a ratio of an SP value of the first resin constituting the sea portion 33A to an SP value of the second resin constituting the island portion 33B), and/or a mixing ratio of the first resin and the second resin. When a ratio of an SP value of the first resin to an SP value of the second resin is large, the sea/island structure may easily be formed.
Specifically, the difference of an SP value of the first resin and an SP value of the second resin is preferably from 2 to 10 (or from about 2 to about 10). When the difference of SP values is within the above range, the sea/island structure may easily be formed.
Ono teaches that an example of a second resin constituting the island portion include polyvinyl butyral (column 3, line 50-column 5, line 10).
Similarly, Ootsuki teaches a polyvinyl acetal resin composition capable of giving a thin film and comprises a polyvinyl acetal resin composition containing a polyvinyl acetal resin A and a polyvinyl acetal resin B incompatible with the polyvinyl acetal resin A, which is formed by acetalizing a mixed polyvinyl alcohol containing two or more kinds of polyvinyl alcohols wherein a phase composed of the polyvinyl acetal resin A and a phase composed of the polyvinyl acetal resin B form a sea-island structure (whole document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the polyvinyl acetate portion of the film of Takeoka with polyvinyl butyral, as identified by Muratoglu, to arrive at the instantly claimed invention. One of ordinary skill in the art would have had a reasonable expectation of success because both Takeoka and Muratoglu are drawn to cell culture components using polyvinyl compounds, Muratoglu identifies polyvinyl acetate (PVac) and polyvinyl butyral (PVB; a polyvinyl acetal resin) art recognized equivalents for the same purpose (MPEP 2144.06), Horodniceanu successfully reduces to practice that polyvinyl butyral is known to be safe for use in cell cultures as a film (Examples), and Ono and Ootsuki identify that polyvinyl butyral is known to be able to form sea-island structures in a film when combined with other polymers. Therefore, there is a reasonable expectation that polyvinyl acetate and polyvinyl butyral were reasonable substitutes for generating a film with a sea-island structure.
Furthermore, the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
The combined teachings of Takeoka, Muratoglu, Horodniceanu, Ono, and Ootsuki do not teach wherein the polyvinyl butyral is conjugated to a peptide with a linker portion.
However, Onofiok teaches a cell culture scaffold material (abstract), comprising a peptide-conjugated polyvinyl alcohol derivative (crosslinked via a linker portion) (paragraphs 5-8 and Fig. 1) having a polyvinyl alcohol derivative portion (Fig. 1), a linker, and a peptide portion, such as RGD (paragraphs 0003-0009 and Fig. 1).
George teaches a polystyrene (PS)-poly(ethylene oxide) (PEO) block copolymer film with functionalized maleimide and an adhesion peptide (GRGDS; referred to as RGD) with phase-separated structures used as part of cell culturing improves cell adhesion to the film (abstract, page 4376, column 1 paragraph 1, and Figures 2 and 4). George teaches that their results demonstrate the ability to directly attach small peptide sequences to the functionalised nanoscale domains through maleimide cysteine linkages and that with increased density (or reduced lateral spacing) of the presented RGD functionalized nanoscale domains that there is increased spreading of NIH-3T3 cells. This outcome shows the potential of these surfaces to affect control over cell behaviour and potentially cell phenotype selection over longer term studies.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the synthetic polyvinyl butyral resin of the combined teachings of Takeoka, Muratoglu, Horodniceanu, Ono, and Ootsuki by linking the synthetic resin with a RGD peptide, as identified by Onofiok and George, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Onofiok teaches polyvinyl alcohol derivates can be conjugated to RGD peptides via a linker and George teaches that their results demonstrate the ability to directly attach small peptide sequences (RGD) to the functionalised nanoscale domains through a linker and that with increased density (or reduced lateral spacing) of the presented RGD functionalized nanoscale domains that there is increased spreading of NIH-3T3 cells. Furthermore, Muratoglu disclose methods of making vinyl polymer hydrogels (abstract) that can be tailored to be populated by a desired class of cells (paragraph 68). Suitable vinyl polymers include both polyvinyl alcohols (PVOH) and polyvinyl butyral (PVB; a polyvinyl acetal resin) (paragraph 43). Therefore, these are art recognized equivalents for the same purpose (MPEP 2144.06). As such, it would have been obvious to make the modification to polyvinyl butyral as this would allow one of ordinary skill in the art to affect control over cell behaviour and potentially cell phenotype selection over longer term studies. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claims 2 and 11, the teachings of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George are as discussed above.
Takeoka teaches that the porous ultra-thin polymer film can include polymethacrylate as a second polymer in the film (column 3, line 8-column 6, line 57). The specification teaches that multiple films with a range of different parameters for the polyvinyl butyral resin and n-lauryl methacrylate (a known polymethacrylate polymer) resin generate a film with the required properties identified in claims 2 and 11. All of the identified example films (Examples 1-11) have the required properties of claims 2 and 11. As the combined film of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George is the same as the film of claim 1 and can include a polymethacrylate polymer, such as lauryl methacrylate, it naturally flows that their combined film would also have the same properties.
MPEP 2112(V) states that the express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). Additionally, MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).
Regarding claim 8, Ono, as stated supra, teaches that an example of a second resin constituting the island portion include polyvinyl butyral (column 3, line 50-column 5, line 10). Therefore, the second phase could be the polyvinyl butyral conjugated to the peptide.
Regarding claim 9, Figure 4 of George teaches that the RGD peptide causes cell adhesion and is, thus, a cell adhesive amino acid sequence.
Regarding claim 12, the film of Takeoka teaches that the phase separated film comprising polyvinyl acetate can be combined with a multitude of other synthetic polymers that are not derived from animal derived raw materials (column 3, line 14-column 8, line 20). Polyvinyl butyral is known to be a type of synthetic polymer that is not derived from animal derived raw materials.
Regarding claim 18, Figure 1 of Onofiok shows that the linker comprises a carboxyl group and Onofiok identifies other possible linkers with a carboxyl group (Figure 1 and paragraph 0038).
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 9938384 (Takeoka) further in view of United States Patent Application No. 20090131548 (Muratoglu), United States Patent No: 4537790 (Horodniceanu), United States Patent No. 8275293 (Ono), United States Patent No. 8431947 (Ootsuki), United States Patent Application No. 20120322145 (Onofiok), and George et al. (Biomaterials 30: 4732–4737. 2009), as applied to claim 1 above and further in view of Wu et al. (J Appl Polym Sci 124: 2154–2170. 2012; previous art of record). This is a new rejection made in response to Applicant’s amendments to claim 1. Applicant’s traversal has been fully considered but is moot in response to the new rejection of record.
The teachings of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George are as discussed above. Takeoka teaches that their film can comprise polystyrene or polyvinyl acetate (column 11, line 57-column 12, line 20).
The combined teachings of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George do not teach wherein the synthetic resin has a cationic functional group.
Wu teaches thin films comprising two different zwitterionic block copolymers (BCs) and a cationic BC were synthesized from the same BC precursor, which consisted of a polystyrene (PS) block and a poly[N-(3-dimethylamino-1-propyl)acrylamide] block (abstract). Wu teaches that these coatings can be used during cell culture to prevent protein adsorption and cell adhesion (page 2154, column 1, paragraph 1-page 2155, column 1, paragraph 2).
Wu teaches that the BCs are tailored to have a water-insoluble block, such as polystyrene (PS), and an antibiofouling, surface-active block (such as films 3-5) (Table 1 and abstract and page 2155, column 1, paragraph 1). As such, the polystyrene and zwitterionic/cationic block polymers would be phase-separated surfaces.
Wu teaches that 77.5 mol% of the BCs were styrene mers, a significant concentration of the ionic mers was present at the surface (page 2162, column 2, paragraph 1). As such, about 77.5 mol% is the polystyrene phase and about 22.5 mol% is the zwitterionic or cationic BC.
Regarding the mol% limitation, the specification discloses that the content (mol%) of the peptide portion is the amount of substance of the peptide portion with respect to the total of the amount of substance of structural units constituting the synthetic resin having a peptide portion (paragraph 0124). As such, a similar method will be used to determine the mol % of the cationic functional group of Wu. Wu teaches that 77.5 mol% of the BCs were styrene mers, a significant concentration of the ionic mers was present at the surface (page 2162, column 2, paragraph 1). As such, about 77.5 mol% is the polystyrene phase and about 22.5 mol% is the zwitterionic or cationic BC of the structural units of the synthetic resin of P(AAmPrDMAAc-r-RfPEGA)-b-PS (3), P(AAmPrDMAPS-r-RfPEGA)-b-PS (4), and P(AAmPrDMABr-r-RfPEGA)-b-PS (5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the synthetic resin film comprising polyvinyl butyral of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George by using a antibiofouling, surface-active block (comprising a cationic functional group (such as a poly[N-(3-dimethylamino-1-propyl)acrylamide] block), as identified by Wu, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Wu teaches that BCs are tailored to have a water-insoluble block, such as polystyrene (PS), and an antibiofouling, surface-active block (such as films 3-5) and polyvinyl butyral is a known water-insoluble polymer. Furthermore, Takeoka and Muratoglu teach that polyvinyl acetate, polyvinyl butyral, and polystyrene are interchangeable. Therefore, it would have been obvious that one could use the polyvinyl butyral in place of the polystyrene as they are art recognized equivalents for the same purpose (MPEP 2144.06) to form a polyvinyl butyral block and a poly[N-(3-dimethylamino-1-propyl)acrylamide] block film as an example. Furthermore, Wu teaches that ionic compounds and zwitterionic compounds are useful in cell culture cell adhesion (page 2154, column 1, paragraph 1-column 2, paragraph 2) and Takeoka teaches that their films can be used in cell culture. As such, it would be obvious that one could make a film comprising polyvinyl butyral and poly[N-(3-dimethylamino-1-propyl)acrylamide] (a polymer comprising a cationic functional group) as polystyrene and polyvinyl butyral are known equivalents (i.e. water insoluble polymers) and Wu successfully reduces to practice that a water-insoluble block and an antibiofouling, surface-active block comprising a cationic functional group can be formed into a coating. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 9938384 (Takeoka) further in view of United States Patent Application No. 20090131548 (Muratoglu), United States Patent No: 4537790 (Horodniceanu), United States Patent No. 8275293 (Ono), United States Patent No. 8431947 (Ootsuki), United States Patent Application No. 20120322145 (Onofiok), and George et al. (Biomaterials 30: 4732–4737. 2009), as applied to claims 1 and 18 above and further in view of Yang et al. (Macromolecular Bioscience 14: 1299-1311. 2014). This is a new rejection.
The teachings of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George are as discussed above. Onofiok teaches that linkers useful in the present invention can be modified with a branching moiety, such as polyethylene glycol. The term "branching moiety" refers to a chemical moiety that links to the polyether polymer via one functional group, and provides at least two other functional groups for linking to the boronic acid groups. Examples of branching moieties include, but are not limited to, lysine, serine, threonine, tyrosine, and cysteine. Other branching moieties can be a lysine derivative, having a carboxylic acid group and both an alpha and omega amine. Other branching moieties are known to one of skill in the art (paragraph 0038).
The combined teachings of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George do not teach wherein the carboxyl group comprises a polymerizable unsaturated group.
Yang teaches that methacrylic acid can be used as a linker to attach RGD to a surface (Scheme 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the linker of Takeoka, Muratoglu, Horodniceanu, Ono, Ootsuki, Onofiok, and George with a methacrylic linker, as identified by Yang, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to substitute with a reasonable expectation of success because Onofiok and Yang are interested in attached RGD molecules to surfaces and Yang successfully reduces to practice that methacrylic acid can be used to attach RGD to a polymer. Therefore, it would have been obvious that one could use the methacrylic acid linker in place of the linker of Onofiok as they are art recognized equivalents for the same purpose (MPEP 2144.06) to attach a RGD molecule to a polymer. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
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 1-4, 8-9, and 11-12 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/608,008 in view of United States Patent No. 9938384 (Takeoka). This is a new rejection made in response to Applicant’s amendments to claim 1.
Regarding claims 1, 3-4, 8-9, and 12, the claims of ‘008 are drawn to a cell culture scaffold material comprising a peptide-conjugated polyvinyl alcohol derivative, such as a polyvinyl acetal resin 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 portions are bound via linker portion. ‘008 claims that the scaffold material has a sea-island structure. ‘008 claims the cell culture scaffold is arranged on a surface of the vessel body (claims 1-5, 7-8, 10-12, and 14-18).
‘008 does not claim wherein the sea-island structure has a ratio of the surface area of one of the first phase and the second phase to the entire surface being 0.01 or more and 0.95 or less.
Takeoka teaches a method of making a phase separated ultra-thin polymer film wherein the phase separated polymers form a sea-island structure. Furthermore, Takeoka teaches that at least one of the polymers can be polyvinyl acetate (abstract and column 3, line 14-column 8, line 20). Takeoka teaches that the film can be used for cell culture (i.e. it is a cell culture scaffold material) (column 12, lines 30-34). Regarding the ratio of the surface area of the first phase to the second phase, Takeoka teaches that the film has a size of preferably 5 cm and may be in the shape of a square (i.e. 5 cm x 5 cm), that the density of the island parts can be 1/μm2, and that the diameter of the island parts can be 0.5 μm. Under this scenario, the ratio of the first to the second phase would be .50 (column 28, line 30-column 29, line 54).
Therefore, it would have been well understood in the art that the sea-island structure could have a ratio of 0.5 with a density of the island parts as 1/μm2.
Regarding claims 2 and 11, the teachings of ‘008 and Takeoka are as discussed above.
Takeoka teaches that the porous ultra-thin polymer film can include polymethacrylate as a second polymer in the film (column 3, line 8-column 6, line 57). The specification teaches that multiple films with a range of different parameters for the polyvinyl acetal resin and n-lauryl methacrylate (a known polymethacrylate polymer) resin generate a film with the required properties identified in claims 2 and 11. All of the identified example films (Examples 1-11) have the required properties of claims 2 and 11. As the combined film of ‘008 and Takeoka is the same as the film of claim 1 and can include a polymethacrylate polymer, such as lauryl methacrylate, it naturally flows that their combined film would also have the same properties.
MPEP 2112(V) states that the express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). Additionally, MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/608,008 in view of United States Patent No. 9938384 (Takeoka) as applied to claim 1 above and further in view of Wu et al. (J Appl Polym Sci 124: 2154–2170. 2012) and United States Patent Application No. 20090131548 (Muratoglu). This is a new rejection made in response to Applicant’s amendments to claim 1.
The teachings of ‘008 and Takeoka are as discussed above. Takeoka teaches that their film can comprise polystyrene or polyvinyl acetate (column 11, line 57-column 12, line 20).
The combined teachings of ‘008 and Takeoka do not teach wherein the synthetic resin has a cationic functional group.
Wu teaches thin films comprising two different zwitterionic block copolymers (BCs) and a cationic BC were synthesized from the same BC precursor, which consisted of a polystyrene (PS) block and a poly[N-(3-dimethylamino-1-propyl)acrylamide] block (abstract). Wu teaches that these coatings can be used during cell culture to prevent protein adsorption and cell adhesion (page 2154, column 1, paragraph 1-page 2155, column 1, paragraph 2).
Wu teaches that the BCs are tailored to have a water-insoluble block, such as polystyrene (PS), and an antibiofouling, surface-active block (such as films 3-5) (Table 1 and abstract and page 2155, column 1, paragraph 1). As such, the polystyrene and zwitterionic/cationic block polymers would be phase-separated surfaces.
Wu teaches that 77.5 mol% of the BCs were styrene mers, a significant concentration of the ionic mers was present at the surface (page 2162, column 2, paragraph 1). As such, about 77.5 mol% is the polystyrene phase and about 22.5 mol% is the zwitterionic or cationic BC.
Regarding the mol% limitation, the specification discloses that the content (mol%) of the peptide portion is the amount of substance of the peptide portion with respect to the total of the amount of substance of structural units constituting the synthetic resin having a peptide portion (paragraph 0124). As such, a similar method will be used to determine the mol % of the cationic functional group of Wu. Wu teaches that 77.5 mol% of the BCs were styrene mers, a significant concentration of the ionic mers was present at the surface (page 2162, column 2, paragraph 1). As such, about 77.5 mol% is the polystyrene phase and about 22.5 mol% is the zwitterionic or cationic BC of the structural units of the synthetic resin of P(AAmPrDMAAc-r-RfPEGA)-b-PS (3), P(AAmPrDMAPS-r-RfPEGA)-b-PS (4), and P(AAmPrDMABr-r-RfPEGA)-b-PS (5).
Muratoglu disclose methods of making vinyl polymer hydrogels (abstract) that can be tailored to be populated by a desired class of cells (paragraph 68). Suitable vinyl polymers include both polyvinyl acetate (PVac) and polyvinyl butyral (PVB; a polyvinyl acetal resin) (paragraph 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the synthetic resin film comprising polyvinyl acetal of ‘008 and Takeoka by using a antibiofouling, surface-active block (comprising a cationic functional group (such as a poly[N-(3-dimethylamino-1-propyl)acrylamide] block), as identified by Wu, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Wu teaches that BCs are tailored to have a water-insoluble block, such as polystyrene (PS), and an antibiofouling, surface-active block (such as films 3-5) and polyvinyl butyral is a known water-insoluble polymer. Furthermore, Takeoka and Muratoglu teach that polyvinyl acetate, polyvinyl butyral, and polystyrene are interchangeable. Therefore, it would have been obvious that one could use the polyvinyl butyral in place of the polystyrene as they are art recognized equivalents for the same purpose (MPEP 2144.06) to form a polyvinyl butyral block and a poly[N-(3-dimethylamino-1-propyl)acrylamide] block film as an example. Furthermore, Wu teaches that ionic compounds and zwitterionic compounds are useful in cell culture cell adhesion (page 2154, column 1, paragraph 1-column 2, paragraph 2) and Takeoka teaches that their films can be used in cell culture. As such, it would be obvious that one could make a film comprising polyvinyl butyral and poly[N-(3-dimethylamino-1-propyl)acrylamide] (a polymer comprising a cationic functional group) as polystyrene and polyvinyl butyral are known equivalents (i.e. water insoluble polymers) and Wu successfully reduces to practice that a water-insoluble block and an antibiofouling, surface-active block comprising a cationic functional group can be formed into a coating. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/608,008 in view of United States Patent No. 9938384 (Takeoka) as applied to claim 1 above and further in view of United States Patent Application No. 20120322145 (Onofiok), George et al. (Biomaterials 30: 4732–4737. 2009), and United States Patent Application No. 20090131548 (Muratoglu). This is a new rejection made in response to Applicant’s amendments to claim 1.
The teachings of ‘008 and Takeoka are as discussed above.
‘008 is silent regarding the specific linker group.
However, Onofiok teaches a cell culture scaffold material (abstract), comprising a peptide-conjugated polyvinyl alcohol derivative (crosslinked via a linker portion) (paragraphs 5-8 and Fig. 1) having a polyvinyl alcohol derivative portion (Fig. 1), a linker, and a peptide portion, such as RGD (paragraphs 0003-0009 and Fig. 1).
George teaches a polystyrene (PS)-poly(ethylene oxide) (PEO) block copolymer film with functionalized maleimide and an adhesion peptide (GRGDS; referred to as RGD) with phase-separated structures used as part of cell culturing improves cell adhesion to the film (abstract, page 4376, column 1 paragraph 1, and Figures 2 and 4). George teaches that their results demonstrate the ability to directly attach small peptide sequences to the functionalised nanoscale domains through maleimide cysteine linkages and that with increased density (or reduced lateral spacing) of the presented RGD functionalized nanoscale domains that there is increased spreading of NIH-3T3 cells. This outcome shows the potential of these surfaces to affect control over cell behaviour and potentially cell phenotype selection over longer term studies.
Muratoglu disclose methods of making vinyl polymer hydrogels (abstract) that can be tailored to be populated by a desired class of cells (paragraph 68). Suitable vinyl polymers include both polyvinyl alcohol (PVac) and polyvinyl butyral (PVB; a polyvinyl acetal resin) (paragraph 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the synthetic polyvinyl acetal resin of the combined teachings of ‘008 and Takeoka by linking the synthetic resin with a RGD peptide, as identified by Onofiok and George, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Onofiok teaches polyvinyl alcohol derivates can be conjugated to RGD peptides via a linker and George teaches that their results demonstrate the ability to directly attach small peptide sequences (RGD) to the functionalised nanoscale domains through a linker and that with increased density (or reduced lateral spacing) of the presented RGD functionalized nanoscale domains that there is increased spreading of NIH-3T3 cells. Furthermore, Muratoglu disclose methods of making vinyl polymer hydrogels (abstract) that can be tailored to be populated by a desired class of cells (paragraph 68). Suitable vinyl polymers include both polyvinyl alcohols (PVOH) and polyvinyl butyral (PVB; a polyvinyl acetal resin) (paragraph 43). Therefore, these are art recognized equivalents for the same purpose (MPEP 2144.06). As such, it would have been obvious to make the modification to polyvinyl butyral as this would allow one of ordinary skill in the art to affect control over cell behaviour and potentially cell phenotype selection over longer term studies. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Figure 1 of Onofiok shows that the linker comprises a carboxyl group and Onofiok identifies other possible linkers with a carboxyl group (Figure 1 and paragraph 0038).
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/608,008 in view of United States Patent No. 9938384 (Takeoka), United States Patent Application No. 20120322145 (Onofiok), George et al. (Biomaterials 30: 4732–4737. 2009), and United States Patent Application No. 20090131548 (Muratoglu) as applied to claims 1 and 18 above and further in view of Yang et al. (Macromolecular Bioscience 14: 1299-1311. 2014). This is a new rejection.
The teachings of ‘008, Takeoka, Onofiok, George, and Muratoglu are as discussed above. Onofiok teaches that linkers useful in the present invention can be modified with a branching moiety, such as polyethylene glycol. The term "branching moiety" refers to a chemical moiety that links to the polyether polymer via one functional group, and provides at least two other functional groups for linking to the boronic acid groups. Examples of branching moieties include, but are not limited to, lysine, serine, threonine, tyrosine, and cysteine. Other branching moieties can be a lysine derivative, having a carboxylic acid group and both an alpha and omega amine. Other branching moieties are known to one of skill in the art (paragraph 0038).
The combined teachings of ‘008, Takeoka, Onofiok, George, and Muratoglu do not teach wherein the carboxyl group comprises a polymerizable unsaturated group.
Yang teaches that methacrylic acid can be used as a linker to attach RGD to a surface (Scheme 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the linker of ‘008, Takeoka, Onofiok, George, and Muratoglu with a methacrylic linker, as identified by Yang, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to substitute with a reasonable expectation of success because Onofiok and Yang are interested in attached RGD molecules to surfaces and Yang successfully reduces to practice that methacrylic acid can be used to attach RGD to a polymer. Therefore, it would have been obvious that one could use the methacrylic acid linker in place of the linker of Onofiok as they are art recognized equivalents for the same purpose (MPEP 2144.06) to attach a RGD molecule to a polymer. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 8-9, 11-12, and 18-19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-10, and 12-14 of copending Application No. 17/608,062 in view of United States Patent No. 9938384 (Takeoka). This is a new rejection made in response to Applicant’s amendments to claim 1.
Regarding claims 1, 3-4, 8-9, 12, and 18-19, the claims of ‘062 are drawn to a cell culture scaffold material comprising a peptide-conjugated polyvinyl acetal resin, having a polyvinyl acetal resin portion and a peptide portion, wherein the peptide portion has a cell adhesive amino acid sequence, such as an RGD sequence, wherein the portions are bound via linker portion. ‘008 claims that the scaffold material has a sea-island structure. ‘008 claims the cell culture scaffold is arranged on a surface of the vessel body. 008’ claims the linker comprises a carboxylic acid having a polymerizable unsaturated group (claims 1-5, 9-10, and 12-14).
‘062 does not claim wherein the sea-island structure has a ratio of the surface area of one of the first phase and the second phase to the entire surface being 0.01 or more and 0.95 or less.
Takeoka teaches a method of making a phase separated ultra-thin polymer film wherein the phase separated polymers form a sea-island structure. Furthermore, Takeoka teaches that at least one of the polymers can be polyvinyl acetate (abstract and column 3, line 14-column 8, line 20). Takeoka teaches that the film can be used for cell culture (i.e. it is a cell culture scaffold material) (column 12, lines 30-34). Regarding the ratio of the surface area of the first phase to the second phase, Takeoka teaches that the film has a size of preferably 5 cm and may be in the shape of a square (i.e. 5 cm x 5 cm), that the density of the island parts can be 1/μm2, and that the diameter of the island parts can be 0.5 μm. Under this scenario, the ratio of the first to the second phase would be .50 (column 28, line 30-column 29, line 54).
Therefore, it would have been well understood in the art that the sea-island structure could have a ratio of 0.5 with a density of the island parts as 1/μm2.
Regarding claims 2 and 11, the teachings of ‘062 and Takeoka are as discussed above.
Takeoka teaches that the porous ultra-thin polymer film can include polymethacrylate as a second polymer in the film (column 3, line 8-column 6, line 57). The specification teaches that multiple films with a range of different parameters for the polyvinyl acetal resin and n-lauryl methacrylate (a known polymethacrylate polymer) resin generate a film with the required properties identified in claims 2 and 11. All of the identified example films (Examples 1-11) have the required properties of claims 2 and 11. As the combined film of ‘062 and Takeoka is the same as the film of claim 1 and can include a polymethacrylate polymer, such as lauryl methacrylate, it naturally flows that their combined film would also have the same properties.
MPEP 2112(V) states that the express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). Additionally, MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-10, and 12-14 of copending Application No. 17/608,062 in view of United States Patent No. 9938384 (Takeoka) as applied to claim 1 above and further in view of Wu et al. (J Appl Polym Sci 124: 2154–2170. 2012) and United States Patent Application No. 20090131548 (Muratoglu). This is a new rejection made in response to Applicant’s amendments to claim 1.
The teachings of ‘062 and Takeoka are as discussed above. Takeoka teaches that their film can comprise polystyrene or polyvinyl acetate (column 11, line 57-column 12, line 20).
The combined teachings of ‘062 and Takeoka do not teach wherein the synthetic resin has a cationic functional group.
Wu teaches thin films comprising two different zwitterionic block copolymers (BCs) and a cationic BC were synthesized from the same BC precursor, which consisted of a polystyrene (PS) block and a poly[N-(3-dimethylamino-1-propyl)acrylamide] block (abstract). Wu teaches that these coatings can be used during cell culture to prevent protein adsorption and cell adhesion (page 2154, column 1, paragraph 1-page 2155, column 1, paragraph 2).
Wu teaches that the BCs are tailored to have a water-insoluble block, such as polystyrene (PS), and an antibiofouling, surface-active block (such as films 3-5) (Table 1 and abstract and page 2155, column 1, paragraph 1). As such, the polystyrene and zwitterionic/cationic block polymers would be phase-separated surfaces.
Wu teaches that 77.5 mol% of the BCs were styrene mers, a significant concentration of the ionic mers was present at the surface (page 2162, column 2, paragraph 1). As such, about 77.5 mol% is the polystyrene phase and about 22.5 mol% is the zwitterionic or cationic BC.
Regarding the mol% limitation, the specification discloses that the content (mol%) of the peptide portion is the amount of substance of the peptide portion with respect to the total of the amount of substance of structural units constituting the synthetic resin having a peptide portion (paragraph 0124). As such, a similar method will be used to determine the mol % of the cationic functional group of Wu. Wu teaches that 77.5 mol% of the BCs were styrene mers, a significant concentration of the ionic mers was present at the surface (page 2162, column 2, paragraph 1). As such, about 77.5 mol% is the polystyrene phase and about 22.5 mol% is the zwitterionic or cationic BC of the structural units of the synthetic resin of P(AAmPrDMAAc-r-RfPEGA)-b-PS (3), P(AAmPrDMAPS-r-RfPEGA)-b-PS (4), and P(AAmPrDMABr-r-RfPEGA)-b-PS (5).
Muratoglu disclose methods of making vinyl polymer hydrogels (abstract) that can be tailored to be populated by a desired class of cells (paragraph 68). Suitable vinyl polymers include both polyvinyl acetate (PVac) and polyvinyl butyral (PVB; a polyvinyl acetal resin) (paragraph 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the synthetic resin film comprising polyvinyl acetal of ‘062 and Takeoka by using a antibiofouling, surface-active block (comprising a cationic functional group (such as a poly[N-(3-dimethylamino-1-propyl)acrylamide] block), as identified by Wu, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Wu teaches that BCs are tailored to have a water-insoluble block, such as polystyrene (PS), and an antibiofouling, surface-active block (such as films 3-5) and polyvinyl butyral is a known water-insoluble polymer. Furthermore, Takeoka and Muratoglu teach that polyvinyl acetate, polyvinyl butyral, and polystyrene are interchangeable. Therefore, it would have been obvious that one could use the polyvinyl butyral in place of the polystyrene as they are art recognized equivalents for the same purpose (MPEP 2144.06) to form a polyvinyl butyral block and a poly[N-(3-dimethylamino-1-propyl)acrylamide] block film as an example. Furthermore, Wu teaches that ionic compounds and zwitterionic compounds are useful in cell culture cell adhesion (page 2154, column 1, paragraph 1-column 2, paragraph 2) and Takeoka teaches that their films can be used in cell culture. As such, it would be obvious that one could make a film comprising polyvinyl butyral and poly[N-(3-dimethylamino-1-propyl)acrylamide] (a polymer comprising a cationic functional group) as polystyrene and polyvinyl butyral are known equivalents (i.e. water insoluble polymers) and Wu successfully reduces to practice that a water-insoluble block and an antibiofouling, surface-active block comprising a cationic functional group can be formed into a coating. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/KEENAN A BATES/Examiner, Art Unit 1631
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