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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16, 19, 25, and 27-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kabanov et al. (US 2013/0017166).
Regarding claims 16 and 19: Kabanov et al. (US ‘166) discloses random copolymers of poly(2-oxazolines) of formula (I) [0019; 0038; 0044] prepared from a hydrophilic monomer (ex. 2-ethyl-2-oxazoline (EtOx) [0042]) and a hydrophobic monomer (ex. 2-butyl-2-oxazoline (BuOx) [0043]), wherein butyl includes sec-butyl (2-sec-butyl-2-oxazoline) [0044]. Kabanov et al. (US ‘166) discloses a copolymer prepared from 2-ethyl-2-oxazoline (EtOx) [0042; 0081] and 2-butyl-2-oxazoline (BuOx) [0043; 0081] P(EtOx50-co-BuOx20) [0082; Table 1]. Additionally, Kabanov et al. (US ‘166) discloses a copolymer prepared from 2-ethyl-2-oxazoline (EtOx) [0042; 0044; 0081] and 2-sec-butyl-2-oxazoline (secBuOx) [0043-0044; 0081], thereby affording P(EtOx50-co-secBuOx20) [0044; 0082; Table 1]; corresponding to instant formula (I) with n = 20; m = 50; (n+m) = 70; R1 = ethyl. If one of ordinary skill in the art is able to “at once envisage” the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be “at once envisaged.” One may look to the preferred embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962) [see MPEP 2131.02].
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) [See MPEP 2113].
Regarding claims 25 and 27: Kabanov et al. (US ‘166) discloses a molar ratio of secBuOx:EtOx of ~ 29:71 [Table 1].
Regarding claim 28: Kabanov et al. (US ‘166) discloses a solution of copolymer (copoly(2-oxazoline)) conjugated with HRP [0069; 0078; 0082-0083].
Regarding claim 29: Kabanov et al. (US ‘166) discloses administering the copolymer (copoly(2-oxazoline)) to a patient (human or animal subject) [0067-0079].
Regarding claim 30: Kabanov et al. (US ‘166) discloses SDS-PAGE assay by mixing the modified HRP with loading buffer and loading the mixture into the gel {casting process} [0083; 0085].
Regarding claim 31: Kabanov et al. (US ‘166) discloses MDCK cells were seeded in 96-well plates at a density of 20,000 cells/well in DMEM and the cells were exposed to the modified HRP [0083; 0090-0091].
Regarding claim 32: Kabanov et al. (US ‘166) discloses pharmaceutical preparations containing the copolymer (copoly(2-oxazoline)) [0067-0069].
Regarding claim 33: Kabanov et al. (US ‘166) discloses a tablet {3D structure} containing the copolymer (copoly(2-oxazoline)) [0072].
Regarding claim 34: Kabanov et al. (US ‘166) discloses creams, gels, ointments, salves {coatings} containing the copolymer (copoly(2-oxazoline)) [0072].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 17-18, 22-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kabanov et al. (US 2013/0017166) as applied to claim 16 above.
Regarding claims 17-18: Kabanov et al. (US ‘166) discloses the basic claimed copolymer [as set forth above with respect to claim 16]; wherein Kabanov et al. (US ‘166) discloses the random copolymers of poly(2-oxazolines) of formula (I) wherein x and y are independently about 5 or more and less than about 300 [0044] {corresponding to x + y ~ 10 to 600}.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Regarding claim 22: Kabanov et al. (US ‘166) discloses the basic claimed copolymer [as set forth above with respect to claim 16]; wherein Kabanov et al. (US ‘166) discloses the hydrophilic monomer can have R = methyl (ex. 2-methyl-2-oxazoline (MeOx)) [0042; 0044].
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 2-methyl-2-oxazoline for 2-ethyl-2-oxazoline based on the invention of Kabanov et al. (US ‘166), and would have been motivated to do so since Kabanov et al. (US ‘166) discloses 2-methyl-2-oxazoline and 2-ethyl-2-oxazoline as hydrophilic monomer [0042; 0044]. Additionally, 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) [see MPEP 2144.06].
Regarding claims 23-24: Kabanov et al. (US ‘166) discloses the basic claimed copolymer [as set forth above with respect to claim 22]; wherein Kabanov et al. (US ‘166) discloses the random copolymers of poly(2-oxazolines) of formula (I) wherein x and y are independently about 5 or more and less than about 300 [0044] {corresponding to x + y ~ 10 to 600}.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Regarding claim 26: Kabanov et al. (US ‘166) discloses the basic claimed copolymer [as set forth above with respect to claim 16]; wherein Kabanov et al. (US ‘166) discloses a molar ratio of secBuOx:EtOx of ~ 29:71 [Table 1]. Kabanov et al. (US ‘166) discloses the random copolymers of poly(2-oxazolines) of formula (I) wherein x and y are independently about 5 or more and less than about 300 [0044].
Kabanov et al. (US ‘166) does not specifically disclose a molar ratio of secBuOx:EtOx of about 50:50 to about 80:20. However, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kabanov et al. (US 2013/0017166) as applied to claim 19 above.
Regarding claims 20-21: Kabanov et al. (US ‘166) discloses the basic claimed copolymer [as set forth above with respect to claim 19]; wherein Kabanov et al. (US ‘166) discloses the random copolymers of poly(2-oxazolines) of formula (I) wherein x and y are independently about 5 or more and less than about 300 [0044] {corresponding to x + y ~ 10 to 600}.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
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 16-28, 30-31 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/029391 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the device comprising the polymer PsecBuOx-stat-PAOx copolymer of formula (I) anticipates the instant claimed PsecBuOx-stat-PAOx copolymer of formula (I) of claims 16-24, and 2D or 3D structure of claim 33. While Application No. 18/029391 does not specifically claim a molar ratio of PsecBuOx:PAOx of about 5:95 to about 95:5 (claim 25); a molar ratio of PsecBuOx:PAOx of about 50:50 to about 80:20 (claim 26); a molar ratio of PsecBuOx:PAOx of about 20:80 to about 50:50 (claim 27), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
The method of creating a 3D structure for cell growth employing the PsecBuOx-stat-PAOx copolymer of formula (I) of Application No. 18/029391 substantially overlaps in scope with the instant claimed fabrication method including the instant claimed PsecBuOx-stat-PAOx copolymer of formula (I) of claims 30-31. While Application No. 18/029391 does not specifically claim electrospinning, fused deposition modelling, thermoforming or casting for step b), it would have been obvious to have created the template by electrospinning, fused deposition modelling, thermoforming or casting, as claim 11 claim electrospinning, fused deposition modelling, thermoforming or casting for step b) [claim 11].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 4/23/26 have been fully considered but they are not persuasive. The rejection of claims based upon Kabanov et al. (US 2013/0017166) is maintained.
Kabanov et al. (US ‘166) was relied on for disclosing random copolymers of poly(2-oxazolines) of formula (I) [0019; 0038; 0044] prepared from a hydrophilic monomer (ex. 2-ethyl-2-oxazoline (EtOx) [0042]) and a hydrophobic monomer (ex. 2-butyl-2-oxazoline (BuOx) [0043]), wherein butyl includes sec-butyl (2-sec-butyl-2-oxazoline) [0044]. Kabanov et al. (US ‘166) discloses a copolymer prepared from 2-ethyl-2-oxazoline (EtOx) [0042; 0081] and 2-butyl-2-oxazoline (BuOx) [0043; 0081] P(EtOx50-co-BuOx20) [0082; Table 1]. Additionally, Kabanov et al. (US ‘166) discloses a copolymer prepared from 2-ethyl-2-oxazoline (EtOx) [0042; 0044; 0081] and 2-sec-butyl-2-oxazoline (secBuOx) [0043-0044; 0081], thereby affording P(EtOx50-co-secBuOx20) [0044; 0082; Table 1]; corresponding to instant formula (I) with n = 20; m = 50; (n+m) = 70; R1 = ethyl. If one of ordinary skill in the art is able to “at once envisage” the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be “at once envisaged.” One may look to the preferred embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962) [see MPEP 2131.02].
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). When a claimed compound is not specifically named in a reference, but instead it is necessary to select portions of teachings within the reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) [see MPEP 2131.02].
A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in 35 U.S.C. § 102(a), in that publication.”). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.) [See MPEP 2131.02].
As Kabanov et al. (US ‘166) discloses butyl includes sec-butyl (2-sec-butyl-2-oxazoline) [0044], and a preferred embodiment being P(EtOx50-co-BuOx20) [0082; Table 1], the copolymer P(EtOx50-co-secBuOx20) prepared from 2-ethyl-2-oxazoline (EtOx) [0042; 0044; 0081] and 2-sec-butyl-2-oxazoline (secBuOx) [0043-0044; 0081] (corresponding to instant formula (I) with n = 20; m = 50; (n+m) = 70; R1 = ethyl [0044; 0082; Table 1]) is anticipated.
Kabanov et al. (US ‘166) discloses a molar ratio of secBuOx:EtOx of ~ 29:71 [Table 1]. Kabanov et al. (US ‘166) discloses the random copolymers of poly(2-oxazolines) of formula (I) wherein x and y are independently about 5 or more and less than about 300 [0044]. While Kabanov et al. (US ‘166) does not specifically disclose a molar ratio of secBuOx:EtOx of about 50:50 to about 80:20, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Applicants can rebut a prima facie case of obvious-ness based on overlapping ranges by showing the crit-icality of the claimed range. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other vari-able within the claims. . . . In such a situation, the applicant must show that the particular range is criti-cal, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 716.02 - § 716.02(g) for a discussion of criticality and unex-pected results [see MPEP 2144.05].
To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). [see MPEP 716.02(d)].
Objective evidence which must be factually sup-ported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991) [see MPEP 716.01(c)].
The nonstatutory double patenting rejection over copending Application No. 18/029391 is maintained {see above}.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL F PEPITONE whose telephone number is (571)270-3299. The examiner can normally be reached on 7:00 AM - 3:30 PM.
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
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