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 .
Election/Restrictions
Newly submitted claims 13-24 are directed to an invention that has a lack of unity with the originally claimed group for the following reasons: The special technical feature is the composition of claim 1, which obvious over Maier (2003/0186829) and the incorporated Haschke et al. (EP 0771329 B1) as demonstrated below.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 13-24 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5-7, 9-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maier (2003/0186829) and the incorporated Haschke et al. (EP 0771329 B1).
Regarding claims 1 and 9-10: Maier teaches a composition comprising polyvinyl acetal (polyvinyl alcohol-based resin) and 1% glycerin monostearate [Examples]. Maier teaches that the average degree of polymerization of between 400 and 1000 [claim 5], and that the polyvinyl acetal is from Haschke et al. [Examples], which is incorporated into the invention of Maier [0014]. The examples of Haschke et al. teach a degree of polymerization of 600 or 700 [Examples]. The composition of Maier is capable of functioning in the claimed capacity. Maier teaches that the composition comprises softeners (plasticizers) in the composition in an amount of between .01 to 70 weight percent [0020], and that the amount of softener is optimized to meet specific requirement profiles, such as processing at a certain temperature, break resistance, and Young’s Elasticity Module [0019]. Maier teaches that the softener is glycerin or propylene glycol [0018, 0036].
The amount of total plasticizer in Maier overlaps the claimed range.
The subject matter as a whole would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, since it has been held that choosing the overlapping portion, of the range taught in the prior art and the range claimed by the applicant, has been held to be a prima facie case of obviousness, see In re Malagari, 182 USPQ 549, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976) and MPEP 2144.05. It would have been obvious to optimize the amount of glycerin in Maier to meet the required profile, such as processing at a certain temperature, break resistance, and Young’s Elasticity Module. It is a result effective variable.
The compound glycerin is very structurally similar to diglycerin, or propylene glycol is very structurally similar to ethylene glycol.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, paragraph II.A.4.(c).
Regarding claims 5-6: Since the polyvinyl alcohol-based resin is the same as claimed, it will possess the claimed properties. The courts have stated that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 15 USPQ2d 1655, (Fed. Cir. 1990). See also In re Best, 562 F.2d 1252, 195 USPQ 430, (CCPA 1977). "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." Further, if it is the applicant's position that this would not be the case, evidence would need to be provided to support the applicant's position.
Regarding claim 7: Maier teaches a degree of saponification of between 80 and 99.5 mole% [0014]. The composition of Maier is capable of functioning in the claimed capacity.
The range of Maier overlaps the claimed range.
The subject matter as a whole would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, since it has been held that choosing the overlapping portion, of the range taught in the prior art and the range claimed by the applicant, has been held to be a prima facie case of obviousness, see In re Malagari, 182 USPQ 549, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976) and MPEP 2144.05.
Regarding claim 12: It is noted that the claimed weight percentage is based upon the dry weight as interpreted by the instant specification. The composition of Maier is polyvinyl acetal (polyvinyl alcohol-based resin), 1% glycerin monostearate [Examples], and between .01 to 70 weight percent softener [0020].
Therefore, the amount of polyvinyl alcohol-based resin overlaps the claimed range.
The subject matter as a whole would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, since it has been held that choosing the overlapping portion, of the range taught in the prior art and the range claimed by the applicant, has been held to be a prima facie case of obviousness, see In re Malagari, 182 USPQ 549, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976) and MPEP 2144.05.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maier (2003/0186829) and the incorporated Haschke et al. (EP 0771329 B1) as applied to claim 1 above further in view of Chen et al. (2016/0160030).
Maier fails to teach an antioxidant.
However, Chen et al. teach adding an antioxidant to polyvinyl acetal resin compositions comprising a plasticizer [0041].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an antioxidant as taught by Chen et al. to the composition of Maier to protect the composition from oxidation damage.
Response to Arguments
Applicant's arguments filed 6/24/2025 have been fully considered but they are not persuasive.
The Applicant has made the argument that the plasticizers in Maier are different than the claimed plasticizers. This is not persuasive because the compound glycerin is very structurally similar to diglycerin, or propylene glycol is very structurally similar to ethylene glycol.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, paragraph II.A.4.(c).
The Applicant has made the argument that Maier fails to teach an example with the claimed amount of plasticizer. This is not persuasive because patents are relevant prior art for all that they contain and not just the preferred embodiments. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). See MPEP 2123.
Maier teaches that the composition comprises softeners (plasticizers) in the composition in an amount of between .01 to 70 weight percent [0020], and that the amount of softener is optimized to meet specific requirement profiles, such as processing at a certain temperature, break resistance, and Young’s Elasticity Module [0019]. The subject matter as a whole would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, since it has been held that choosing the overlapping portion, of the range taught in the prior art and the range claimed by the applicant, has been held to be a prima facie case of obviousness, see In re Malagari, 182 USPQ 549, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976) and MPEP 2144.05. It would have been obvious to optimize the amount of glycerin in Maier to meet the required profile, such as processing at a certain temperature, break resistance, and Young’s Elasticity Module. It is a result effective variable.
The Applicant has made the argument that Maier fails to teach the claimed amount of polyvinyl alcohol-based resin. It is noted that the claimed weight percentage is based upon the dry weight as interpreted by the instant specification. The composition of Maier is polyvinyl acetal (polyvinyl alcohol-based resin), 1% glycerin monostearate [Examples], and between .01 to 70 weight percent softener [0020].
Therefore, the amount of polyvinyl alcohol-based resin overlaps the claimed range.
The subject matter as a whole would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, since it has been held that choosing the overlapping portion, of the range taught in the prior art and the range claimed by the applicant, has been held to be a prima facie case of obviousness, see In re Malagari, 182 USPQ 549, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976) and MPEP 2144.05.
The Applicant has made the argument that the capsule shells are completely different from a water-soluble core for injection molding. This is not persuasive because the instant claims are for a resin composition with an intended use as a core. The structural limitations of the claims is met by the cited references.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 and 9-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 17/796480. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment and Information Disclosure Statement filed 5/22/2025 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN USELDING whose telephone number is (571)270-5463. The examiner can normally be reached on M-F 8am to 6:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Del Sole can be reached on 571-272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN E USELDING/ Primary Examiner, Art Unit 1763