Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendments
Applicant’s amendments, IDS, and response filed Aug. 6, 2026 have been received and entered into the case.
Status of the Claims
Claims 1, 5-7, 14-16, 20-21, 25-27, 32-34, 38-39, 43-47 and 146 are currently pending.
Claims 1, 5, 14, 16, 20, 25-26, 32 and 38 are amended.
Claims 20, 21, and 25 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or Invention, there being no allowable generic or linking claim.
Claims 2-4, 8-13, 17-19, 22-24, 28-31, 35-37, 40-42, and 48-145 are cancelled.
Claim 146 is new.
Claims 1, 5-7, 14-16, 26-27, 32-34, 38-39, 43-47 and 146 have been considered on the merits.
Specification Objections
Specification objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment.
Claim Rejections - 35 USC § 102
The claim rejections under 35 USC § 102 are withdrawn due to amendment.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are revised due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments.
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, 5-7, 14-16, 26, 27, 32-34, 38, 39, 43-47 and 146 are rejected under 35 U.S.C. 103 as being unpatentable over Vallier et al. (US 2015/0225698 A1) as evidenced and in view of Kuriyama et al. (US 2017/0009200 A1).
With respect to claim 1, Vallier teaches an in vitro composition containing a plurality of pancreatic β precursor cells and a culture medium containing polyvinyl alcohol (CDM-PVA) (0008-0014 and 0042). With respect to claims 1 and 14, Vallier teaches the pancreatic β cells express insulin and NKX6.1, the pancreatic β precursor cells express NKX6.1 and PDX1 and that INS (insulin), PDX1, are NKX6.1 are pancreatic markers (Fig. 1, 0108, 0116, 0162 and 0217).
Vallier is silent with respect to the percentage of hydrolyzed PVA and does not teach the composition where the PVA is less than 85% hydrolyzed as recited in claim 1 or where the PVA is about 75-85% hydrolyzed as recited in claim 146.
However, Kuriyama teaches a cell culture medium for stem cells containing a water-soluble polymer which can be polyvinyl alcohol as a substitute for albumin (0009, 0015, and 0023). Kuriyama teaches the PVA with a hydrolysis of 75-90% and when the hydrolysis ratio is too low, water-solubility is not sufficient and, when it is too high, hydroxyl groups of polymers form a hydrogen bond to lower the solubility and dispersibility in water (0059).
Accordingly, at the effective time of filing of the claimed invention one of ordinary skill in the art would have been motivated to modify the cell culture medium of Vallier so that the PVA included has a percentage of hydrolyzed PVA that is less than 85% and/or between 75-85%, for the benefit of effectively culturing the cells as taught by Kuriyama. It would have been obvious to one of ordinary skill in the art to use PVA with these percentages of hydrolysis, since these percentages were known in the art to culture cells in medium without albumin as taught by Kuriyama. Additionally, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Vallier, since these were known percentages for cell culture as taught by Kuriyama. Although Kuriyama does not teach the exact ranges recited in claims 1 and 146, the ranges overlap significantly with the ranges taught. Furthermore, one of ordinary skill in the art would recognize that the percentage of hydrolysis of PVA in a medium is a result effective variable and that the percentage of hydrolysis of PVA would be matter of routine optimization as evidenced by Kuriyama. Kuriyama teaches when the hydrolysis ratio is too low, water-solubility is not sufficient and, when it is too high, hydroxyl groups of polymers form a hydrogen bond to lower the solubility and dispersibility in water (0059).
With respect to claim 5, Vallier teaches 1 mg/ml of PVA (polyvinyl alcohol) or 0.1% w/v (0042).
With respect to claims 15 and 16, Vallier teaches a stage 1 medium containing Activin-A and bFGF; a stage 2 medium containing SB-431542, FGF10, all-trans retinoic acid and Noggin; a stage 3 medium containing FGF10, all-trans retinoic acid, KAAD-cyclopamine and Noggin; a stage 4 medium containing FGF10; and maturation medium containing B27™ and DAPT (0201).
With respect to claim 26, Vallier teaches the composition where the pancreatic β precursor cells are FOXA2-positive primitive foregut cells (0099). With respect to claim 27, Vallier teaches the composition where the FOXA2-positive primitive foregut cells are in a medium containing the second or third pancreatic induction medium (stage 2 or stage 3) medium. Stage 2 contains SB-431542 (TGF-β singling pathway inhibitor), FGF10, all-trans retinoic acid (retinoic acid signaling pathway activator) and Noggin and stage 3 contains FGF10, all-trans retinoic acid, KAAD-cyclopamine and Noggin (0201).
With respect to claim 32, Vallier teaches the composition where the pancreatic β precursor cells are SOX17-positive definitive endoderm cells (Fig. 1 and 0010-0011). With respect to claims 33 and 34, Vallier teaches the composition where the SOX17-positive definitive endoderm cells are in a medium containing the stage 1 or stage 2 medium (Fig. 1). Stage 1 medium contains Activin-A and bFGF and stage 2 contains SB-431542, FGF10, all-trans retinoic acid and Noggin (0010-0011 and 0201).
With respect to claims 38 and 44, Vallier teaches the composition where the pancreatic β precursor cells are pluripotent stem cells (Fig. 1, 0007, 0009). With respect to claim 39, Vallier teaches the composition where the pluripotent stem cells are in a definitive induction medium containing TGF-β, FGF, BMP, a PI3K inhibitor, BMP and optionally a GSK3 β inhibitor (0009-0010). With respect to claim 43, Vallier teaches the composition containing SOX17-positive definitive endoderm cells which would include pluripotent stem cells as they differentiate (Fig. 1 and 0093). With respect to claim 44, Vallier teaches the composition where the pancreatic β precursor cells are human pluripotent stem cells (Fig. 1 and 0018). With respect to claim 45, Vallier teaches the composition where the pluripotent stem cells are embryonic stem cells or induced pluripotent stem cells (0020).
With respect to claims 46 and 47, Vallier teaches the culture medium not containing any albumin (0040).
Vallier does not teach the composition where the water-soluble polymer is at a concentration of about 0.04-0.06% w/v in the culture medium as recited in claim 6 or at a concentration of about 0.05% w/v in the culture medium as recited in claim 7. However, one of ordinary skill in the art would recognize that the concentration of the water-soluble polymer in the culture medium is a result effective variable and that the concentration of the water-soluble polymer would be matter of routine optimization as evidenced by Kuriyama. Kuriyama teaches a cell culture medium for stem cells containing a water-soluble polymer which can be polyvinyl alcohol as a substitute for albumin (0009, 0015, and 0023). Kuriyama teaches that the amount of a medium additive, water-soluble polymer, that is added to the basal medium is determined depending on desired effect and the kind of water-soluble polymer added (0067). Kuriyama further teaches that when the concentration of the water-soluble polymer is too low there may be affect and when it is too high it might cytotoxic (0062). Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) -MPEP § 2144.05.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
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, 5-7, 14-16, 26, 27, 32-34, 38, 39, 43-47 and 146 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 7-10, 12-14 and 142 of copending Application No. 18/647137 as evidenced by Kuriyama et al. (US 2017/0009200 A1) in view of Vallier et al. (US 2015/0225698 A1). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim in vitro compositions containing a population of pancreatic progenitor cells and the culture medium contains a water-soluble synthetic polymer.
Claims 1 and 10 of application No. 18/647137 recites the limitations of instant claims 1 and 14, of an in vitro composition containing a population of pancreatic progenitor cells in a culture medium where the pancreatic progenitor cells are PDX1-positive and NKX6.1 positive and the medium contains a water-soluble synthetic polymer. Claim 12 of application No. 18/647137 recites the limitations of instant claim 1, where the water-soluble synthetic polymer comprises polyvinyl alcohol. Claim 14 of application No. 18/647137 recites the limitations of instant claim 1, where the water-soluble synthetic polymer comprises polyvinyl alcohol that is at most 85% hydrolyzed.
Claim 13 of application No. 18/647137 recites the limitations of instant claim 5, where the water- soluble synthetic polymer is present at a concentration of about 0.005% to about 0.5% (w/v), about 0.01% to about 0.2% (w/v), about 0.02% to about 0.1% (w/v), or about 0.03% to about 0.08% (w/v) in the culture medium.
The claims of application No. 18/647137 do not recite the limitations of instant claim 6, where the water- soluble synthetic polymer is present at a concentration of about 0.04% to about 0.06% (w/v) in the culture medium. The claims of application No. 18/647137 do not recite the limitations of instant claim 7, where the water- soluble synthetic polymer is present at a concentration of about 0.05% (w/v) in the culture medium. However, one of ordinary skill in the art would recognize that the concentration of the water-soluble polymer in the culture medium is a result effective variable and that the concentration of the water-soluble polymer would be matter of routine optimization as evidenced by Kuriyama. Kuriyama teaches a cell culture medium for stem cells containing a water-soluble polymer which can be polyvinyl alcohol as a substitute for albumin (0009, 0015, and 0023). Kuriyama teaches that the amount of a medium additive, water-soluble polymer, that is added to the basal medium is determined depending on desired effect and the kind of water-soluble polymer added (0067). Kuriyama further teaches that when the concentration of the water-soluble polymer is too low there may be affect and when it is too high it might cytotoxic (0062).
Claims 2, 3, 8 and 9 of application No. 18/647137 recites the limitation of the in vitro composition further containing a PKC activator, γ-secretase inhibitor, RA (retinoic acid)(a retinoic acid (RA) signaling pathway activator), a sonic hedgehog (SHH) pathway inhibitor, a Rho-associated, coiled-coil containing protein kinase (ROCK) inhibitor, as disclosed in instant claim 15. Claims 4, 7-9 and 142 of application No. 18/647137 recites the limitations of the in vitro composition further containing a y-secretase inhibitor comprising XXI or DAPT, retinoic acid, Thiazovivin, SANT1, protein kinase C activator selected from the group consisting of: phorbol 12,13- dibutyrate (PDBU), TPB, phorbol 12-myristate 13-acetate, and bryostatin 1 as disclosed in instant claim 16.
The claims of application No. 18/647137 do not recite the limitations of instant claim 26, where the composition comprises precursor cells of the pancreatic β cells which comprise a plurality of FOXA2-positive primitive gut cells. Similarly, the claims of application No. 18/647137 do not recited the limitations of instant claim 27, where the culture medium of the composition containing FOXA2-positive primitive gut cells further comprises one or more agents selected from the group consisting of: a protein kinase C activator, a growth factor from transformation growth factor 3 (TGF-(3) superfamily, a bone morphogenetic protein signaling pathway inhibitor, a growth factor from fibroblast growth factors (FGF) family, a retinoic acid (RA) signaling pathway activator, a Rho-associated, coiled- coil containing protein kinase (ROCK) inhibitor, and a sonic hedgehog (SHH) pathway inhibitor.
The claims of application No. 18/647137 do not recite the limitations of instant claim 32, where the composition comprises precursor cells of the pancreatic β cells which comprise a plurality of SOX17-positive definitive endoderm cells. Similarly, the claims of application No. 18/647137 do not recite the limitations of instant claims 33 and 34, where the culture medium of the composition containing SOX17-positive definitive endoderm cells further comprises a growth factor from fibroblast growth factors (FGF) family or where the FGF is selected from the group consisting of: keratinocyte growth factor (KGF), FGF2, FGF10, FGF21, and FGF8B.
The claims of application No. 18/647137 do not recite the limitations of instant claims 38, 44 or 45, where the composition comprises precursor cells of the pancreatic β cells which comprise a plurality of pluripotent stem cells (PSCs), where the PSCs are human or where the PSCs are embryonic stem cells or iPSCs. Similarly, the claims of application No. 18/647137 do not recite the limitations of instant claim 39, where the culture medium of the composition containing pluripotent stem cells further comprises a growth factor from transformation growth factor p (TGF-(3) superfamily, a WNT signaling pathway activator, or both. The claims of application No. 18/647137 do not recite the limitations of instant claim 39, where the composition comprising the plurality of PSC further contains SOX17-positive cells.
However, Vallier teaches an in vitro composition containing a plurality of pancreatic β cells or precursor cells and a culture medium containing polyvinyl alcohol (CDM-PVA) (0008-0014 and 0042). With respect to claim 26, Vallier teaches the composition where the pancreatic β precursor cells are FOXA2-positive primitive foregut cells (0011-0012 and 0099). With respect to claim 27, Vallier teaches the composition where the FOXA2-positive primitive foregut cells are in a medium containing the second or third pancreatic induction medium (stage 2 or stage 3) medium. Stage 2 contains SB-431542, FGF10, all-trans retinoic acid and Noggin and stage 3 contains FGF10, all-trans retinoic acid, KAAD-cyclopamine and Noggin (0011 and 0201). With respect to claim 32, Vallier teaches the composition where the pancreatic β precursor cells are SOX17-positive definitive endoderm cells (Fig. 1 and 0010-0011). With respect to claims 33 and 34, Vallier teaches the composition where the SOX17-positive definitive endoderm cells are in a medium containing the stage 1 or stage 2 medium (Fig. 1). Stage 1 medium contains Activin-A and bFGF and stage 2 contains SB-431542, FGF10, all-trans retinoic acid and Noggin (0010-0011 and 0201). With respect to claims 38 and 44, Vallier teaches the composition where the pancreatic β precursor cells are pluripotent stem cells (Fig. 1, 0007, 0009). With respect to claim 39, Vallier teaches the composition where the pluripotent stem cells are in a definitive induction medium containing TGF-β, FGF, BMP, a PI3K inhibitor, BMP and optionally a GSK3 β inhibitor (0009-0010). With respect to claim 43, Vallier teaches the composition containing SOX17-positive definitive endoderm cells which would include pluripotent stem cells as they differentiate (Fig. 1 and 0093). With respect to claim 44, Vallier teaches the composition where the pancreatic β precursor cells are human pluripotent stem cells (Fig. 1 and 0018). With respect to claim 45, Vallier teaches the composition where the pluripotent stem cells are embryonic stem cells or induced pluripotent stem cells (0020).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the composition of application No. 18/647137 so that the pancreatic β cells and/or precursor cells further include the additional pancreatic cell types and additional culture components listed in claims 26-27, 32-34, 38-39, and 43-45 with these pancreatic cell types, for the benefit of culturing additionally known pancreatic cell types as taught by Vallier. It would have been obvious to one of ordinary skill in the art to include additionally known pancreatic cell types in the pancreatic cell composition of application No. 18/647137, since these cells were known in the art to be included in culture medium with the claimed factors as taught by Vallier. Additionally, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to application No. 18/647137, since these were known pancreatic cell types which are included in in vitro cultures with the claimed factors as taught by Vallier.
The claims of application No. 18/647137 do not recite the limitations of instant claim 46, where the culture medium does not comprise an albumin protein. Similarly, The claims of application No. 18/647137 do not recite the limitations of instant claim 47, where the culture medium does not comprise a human serum albumin (HSA).
However, Vallier teaches an in vitro composition containing a plurality of pancreatic β cells or precursor cells and a culture medium containing polyvinyl alcohol (CDM-PVA) (0008-0014 and 0042). Vallier teaches the culture medium not containing any albumin so that the medium is chemically defined and there are no unknown components (0040).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the composition of application No. 18/647137 so that the medium does not include albumin protein or human serum albumin, for the benefit of having chemically defined medium as taught by Vallier. It would have been obvious to one of ordinary skill in the art to exclude albumin in the culture medium composition of application No. 18/647137, since these cells were known in the art to be included in culture medium that do not contain albumin as taught by Vallier. Additionally, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to application No. 18/647137, since similar compositions containing pancreatic cells and a culture medium with a water-soluble synthetic polymer as taught by Vallier.
The claims of application No. 18/647137 do not recite the limitations of instant claim 146, where the water- soluble synthetic polymer comprises polyvinyl alcohol that is about 75% to 85% hydrolyzed. However, one of ordinary skill in the art would recognize that the percentage of hydrolysis of the PVA in the culture medium is a result effective variable and that the percentage of hydrolysis of PVA would be matter of routine optimization as evidenced by Kuriyama. Kuriyama teaches a cell culture medium for stem cells containing a water-soluble polymer which can be polyvinyl alcohol as a substitute for albumin (0009, 0015, and 0023). Kuriyama teaches that the amount of a medium additive, water-soluble polymer, that is added to the basal medium is determined depending on desired effect and the kind of water-soluble polymer added (0067). Kuriyama teaches the PVA with a hydrolysis of 75-90% and when the hydrolysis ratio is too low, water-solubility is not sufficient and, when it is too high, hydroxyl groups of polymers form a hydrogen bond to lower the solubility and dispersibility in water.
Response to Arguments
Applicant's arguments filed Aug. 6, 2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. §102 and §103, Applicant argues that Vallier does not teach the hydrolyzation of the polyvinyl alcohol in the medium being 85% or less hydrolyzed as presently claimed and teaches a hydrolyzation that is greater than 85% (Remarks pg. 9 para. 4 and pg. 10 para. 2). The Applicant’s amendments limiting the hydrolyzation of the polyvinyl alcohol in the medium to being 85% or less hydrolyzed necessitated the withdrawal of previous rejection. Applicant’s arguments are drawn to Vallier failing to teach this new limitation. However, this new limitation is addressed in the new rejection. Briefly, Kuriyama teaches a cell culture medium for stem cells containing a water-soluble polymer which can be polyvinyl alcohol as a substitute for albumin (0009, 0015, and 0023). Kuriyama teaches the PVA with a hydrolysis of 75-90% and when the hydrolysis ratio is too low, water-solubility is not sufficient and, when it is too high, hydroxyl groups of polymers form a hydrogen bond to lower the solubility and dispersibility in water (0059). One of ordinary skill in the art would have been motivated to modify the cell culture medium of Vallier so that the PVA included has a percentage of hydrolyzed PVA that is less than 85% and/or between 75-85%, for the benefit of effectively culturing the cells as taught by Kuriyama and since these percentages were known in the art to culture cells in medium without albumin as taught by Kuriyama. Additionally, one of ordinary skill in the art would recognize that the percentage of hydrolysis of PVA in a medium is a result effective variable and that the percentage of hydrolysis of PVA would be matter of routine optimization as evidenced by Kuriyama.
Further with respect to the rejections under 35 U.S.C. §102, Applicant submits as evidence, Exhibit A (Sampaziotis) demonstrates that Vallier teaches a 87-90% hydrolyzed PVA. Specifically, Sampaziotis, which includes Vallier as a co-author, discloses a 87-90% hydrolyzed PVA (Remarks pg. 9 para. 5). These arguments are moot, since the rejections under 35 U.S.C. §102 have been withdrawn. However, it is noted that Sampaziotis does not support the notion that Vallier teaches a 87-90% hydrolyzed PVA, since Vallier does not reference Sampaziotis for support of their composition or for the hydrolysis percentage of the PVA.
With respect to the rejections under 35 U.S.C. §103, Applicant argues that Kuriyama does not teach the claimed range of hydrolyzation of the PVA and instead teaches a PVA that is greater than 85% (Remarks pg. 10 para. 3). The Applicant’s amendments limiting the hydrolyzation of the polyvinyl alcohol in the medium being 85% or less hydrolyzed necessitated the withdrawal of previous rejection. Applicant’s arguments are drawn to Kuriyama failing to teach this new limitation. However, this new limitation is addressed in the new rejection. Briefly, as explained above, Kuriyama teaches the PVA with a hydrolysis of 75-90% and when the hydrolysis ratio is too low, water-solubility is not sufficient and, when it is too high, hydroxyl groups of polymers form a hydrogen bond to lower the solubility and dispersibility in water (0059).
Applicant argues that Harb does not remedy the deficiencies of Vallier and Kuriyama (Remarks pg. 10 para. 7). Applicant' s arguments with respect to Harb have been considered but are moot because Harb is no longer a reference being used in the current set of rejections.
Applicant requests that the provisional double patenting rejections over U.S. Appl. No. 18/647137 be withdrawn, since the present application has an earlier filing date (Remarks pg. 11 para. 2). The provisional double patenting rejections will be maintained should U.S. Appl. No. 18/647137 issue before this one does.
Applicant notes that the IDS filed on Mar. 12, 2024 was not considered. The information disclosure statement has been considered by the examiner in the present action.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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