DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/05/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/05/2026 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 05/05/2026 in which claims 2-4, 15, 28-29, and 31 were canceled; claims 21-27 were withdrawn; claims 9 and 19 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 1, 5-14, 16-20, 30, and 32-34 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Objection
Claim Objections
Claim 9 is objected to because of the following informalities: the recitation of “a vegan source is selected from … and hemp proteins” is an improper Markush language. When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper. Appropriate correction is required.
Maintained Rejections
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.
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.
Claim(s) 1, 5-12, 16-17, 19-20, 30 and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al (US 2011/0117180 A1) in view of Ludvik et al (US 2013/0211005 A1).
Regarding claims 1 and 30, Yan teaches a composition comprising microcapsules comprising a core encapsulating a biologically active substance, and a shell surrounding the core, the shell is formed by complex coacervation of a vegetable protein and a polyelectrolyte with an opposite charge to the protein (Abstract; [0006]-[0049], [0060], [0068]-[0092], [0098]-[0131]; claims 1, 6-8, 19 and 35-37). Yan teaches the microcapsules further contain a crosslinking agent ([0090]-[0091]). Yan teaches a consumer product containing the composition ([0105]-[0116]). Yan teaches the crosslinking agent is a dialdehyde such as glutaraldehyde and the crosslinking agent crosslinks the protein and the polyelectrolyte ([0090]-[0091]).
While Yan does not expressly teach the crosslinking agent is a cyclic dialdehyde, it would have been obvious to use and incorporate a cyclic dialdehyde as the crosslinking agent in the microcapsule of Yan in view of the guidance from Ludvik.
Ludvik teaches a polymer microparticles a reaction mixture of a polymer, polysaccharide, and a crosslinking agent, wherein the crosslinking agent is an dialdehyde including glutaraldehyde and isophthalaldehyde (Abstract; [0016]-[0020], [0065]-[0077], [0145], [0241]-[0245]).
It would have been obvious to one of ordinary skill in the art use and incorporate a cyclic dialdehyde as the crosslinking agent in the microcapsule of Yan, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Ludvik provided the guidance to do so by teaching that aside from glutaraldehyde, cyclic or aromatic dialdehyde including isophthalaldehyde is also known to be a suitable dialdehyde crosslinker used in forming polymeric microparticles/microcapsules (Ludvik: [0065]-[0071]). Thus, it would have been merely simple substitution of one known dialdehyde crosslinker for another to obtain predictable results of polymeric microparticles/microcapsules, and achieve Applicant’s claimed invention with reasonable expectation of success. As such, it is noted that [t]he 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.).\
Regarding claim 5, as discussed above, Yan teaches vegetable protein, thereby meeting the claimed the first polyelectrolyte is ampholyte.
Regarding claim 6, Yan teaches the vegetable protein has an isoelectric point below pH 7 ([0072]; Table 4).
Regarding claim 7, Yan teaches the protein and the polysaccharide are solubilized in water to form solutions ([0072]-[0077]). Thus, it would have been reasonable obvious that the claimed property of “the solubility of the first and section polyelectrolytes is higher than 5 wt.% in water at pH 7 ± 0.5 and at room temperature” would have been implicit in the protein and polysaccharide of Yan. It is noted that [w]here 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). It is further noted that [p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Regarding claim 8, as discussed above, Yan teaches vegetable protein.
Regarding claim 9, Yan teaches the vegetable protein is soy protein or pea protein ([0042], [0068], [0072]; claim 8).
Regarding claim 10, Yan teaches the protein is a pea protein concentrate or a soy protein concentrate, and said protein is solubilized in water to form a protein solution ([0042], [0068], [0072]-[0077]; claim 8). Thus, it would have been reasonably obvious and implicit that the protein at a nominal percentage of 5 wt.% would contain less than 0.1 wt.% of insoluble material based on the total weight of the solution as claimed because as discussed above, the protein was solubilized in water to form a protein solution. It is noted that [w]here 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claims 11 and 12, Yan teaches polyelectrolyte is polysaccharide selected from gellan gum, pectin, low methoxyl pectin, gum arabic, alginate, carboxymethyl-cellulose or a mixture thereof ([0041]-[0042]; claim 19).
Regarding claim 16, as discussed above, Ludvik taught and provided the guidance for using isophthalaldehyde as the dialdehyde crosslinker.
Regarding claim 17, Yan teaches the crosslinking agent is present in an amount from 0.1% to about 5.0% by weight, and can be added at any stage of the process of preparing the microcapsule ([0090]-[0091]). It would have been obvious one of ordinary skill in the art to routinely optimize the amount of crosslinking agent in the composition to an amount from 0.1% to about 5.0% by weight based on the weigh to the core composition, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Yan provides the direct guidance for optimizing the amount of crosslinking agent in the composition irrespective of when it is added the process of the preparing the microcapsules, can be from 0.1% to about 5.0% by weight, as one skilled in the art can routinely determine the desired amount in any giving case by simple experimentation ([0090]-[0091]).
Regarding claim 19, as discussed above, Yan teaches the core contains a biologically active substance.
Regarding claim 20, Yan teaches the microcapsules has a diameter from 1-5 µm ([0152]-[0169]), which falls within the claimed range of “the volume median diameter of the microcapsules (Dv(50)) is from 1 to 150 µm. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of volume median diameter of the microcapsules would have been obvious before the effective filing date of applicant's invention. “Where 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). See MPEP §2144.05 (I)-(II).
Regarding claim 32, as discussed above, Yan teaches the vegetable protein is soy protein or pea protein.
Regarding claim 33, as discussed above, Yan teaches polyelectrolyte is polysaccharide selected from gellan gum, pectin, low methoxyl pectin, gum arabic, alginate, carboxymethyl-cellulose or a mixture thereof.
Regarding claim 34, as discussed above, Yan teaches carboxymethylcellulose as one of the preferred polyelectrolyte.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al (US 2011/00117080 A1) in view of Ludvik et al (US 2013/0211005 A1), as applied to claim 34 above, and further in view of Duhoranimana et al (Food Hydrocolloids, 2017, 69: 111-120).
The encapsulated composition of claim 34 is discussed above, said discussion being incorporated herein in its entirety.
However, Yan and Ludvik do not teach the molecular weight of the carboxymethylcellulose of claim 13,
Regarding claim 13, Duhoranimana microcapsules formed by complex coacervation of a protein and a polysaccharide such as carboxymethyl cellulose (Abstract; pages 111-112; page 116 and Table 1; page 119). Duhoranimana teaches suitable carboxymethylcellulose for complex coacervate with a protein is carboxymethylcellulose having molecular weights 108 kDa and DS 1.03 and molecular weights 183 kDa and DS 0.95, as said carboxymethylcellulose form stable complex coacervate (pages 111-112; page 116 and Table 1).
It would have been obvious to one of ordinary skill in the art to incorporate carboxymethylcellulose having molecular weight 108 kDa and DS 1.03 or molecular weights 183 kDa and DS 0.95, as the polyelectrolyte (polysaccharide) in the microcapsule of Yan, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Yan indicated that any carboxymethylcellulose is suitable for use as the polyelectrolyte, and Duhoranimana provide the direct guidance for using carboxymethylcellulose having molecular weight 108 kDa and DS 1.03 or molecular weights 183 kDa and DS 0.95 as the carboxymethylcellulose (polysaccharide) so as to provide a stable complex coacervate with the protein. Thus, an ordinary artisan seeking to maximize the stability of the resultant microcapsule would have looked to incorporate carboxymethylcellulose having molecular weight 108 kDa and DS 1.03 or molecular weights 183 kDa and DS 0.95, as the polyelectrolyte (polysaccharide) in the microcapsule of Yan, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al (US 2011/00117080 A1) in view of Ludvik et al (US 2013/0211005 A1), as applied to claims 8 and 34, respectively above, and further in view of Yan et al (US 2005/0067726 A1; hereafter as Yan ‘726).
The encapsulated composition of claims 8 and 34 are discussed above, said discussion being incorporated herein in its entirety.
However, Yan ‘080 and Ludvik do not teach the weight ratio of carboxymethylcellulose to protein of claim 14 and the weight ratio of the interfacial enabler to the protein to claim 18.
Regarding claims 14 and 18, Yan ‘726 teaches microcapsules formed by complex coacervate of a protein and a polysaccharide, wherein suitable protein include soy protein, and suitable polysaccharide include gum Arabic, pectin or carboxymethylcellulose (Abstract; [0008]-[0073]; claims 16-30). Yan ‘726 teaches the microcapsules encapsulate a hydrophobic liquid ([0028], [0055]-[0056]). Yan ‘726 teaches the microcapsules contain an aldehyde crosslinking agent ([0068]). Yan ‘726 teaches the concentration of the protein in the microcapsule composition is from 1-15% by weight and the concentration of the polysaccharide in the microcapsule composition is from 0.01-0.65% by weight ([0064]). Yan ‘726 teaches concentration of the crosslinking agent in the microcapsule composition is from about 0.2% to about 2.0% by weight ([0068]). Yan indicated that one skilled in the art can routinely determine the desired amount of protein, polysaccharide, and crosslinking agent in any given case by simple experimentation ([0068]).
It would have been obvious to one of ordinary skill in the art to optimize the weight amounts of protein, polysaccharide (carboxymethyl cellulose), and crosslinking agent in the microcapsule of Yan ‘080 to weight ratios as claimed in claims 14 and 18, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Yan ‘726 provide guidance for optimizing the concentration of the protein in the microcapsule composition to from 1-15% by weight, the concentration of the polysaccharide in the microcapsule composition to be from 0.01-0.65% by weight, and the concentration of the crosslinking agent in the microcapsule composition to be from about 0.2% to about 2.0% by weight (Yan ‘726: [0064] and [0068]). The weight amounts of protein, polysaccharide, and crosslinking agent as taught by Yan ‘726 overlap or fall within the claimed weight ratios as recited in claims 14 and 18. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of weigh ratio of carboxymethylcellulose to protein and weight ratio of interfacial enabler to protein in a microcapsule would have been obvious before the effective filing date of applicant's invention. “Where 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). See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 05/05/2026 have been fully considered but they are not persuasive.
Applicant argues:
“Tables 1 and 2 of the present application show that the encapsulation efficiency in the presence of a cyclic dialdehyde according to the present invention (examples 2.2 - 2.7 and 2.10 - 2.14) is unexpectedly superior to the encapsulation efficiency when only glutaraldehyde (example 2.1) or only transglutaminase (example 2.9) have been employed as cross-linkers, which is in accordance with the teachings of the closest prior art (Yan).” (Remarks, page 6, 5th paragraph).
In response, the Examiner disagrees. The alleged unexpected superior data shown in Tables 1 and 2 from Example 2 of the specification are considered, but found insufficient to obviate the pending 103 rejections because the results from Table 1 and 2 per instant specification are as follows:
“The results of Table 1 and Table 2 show that the microcapsules obtained in the presence of 0.25 wt.-% and more of enabler have a better encapsulation efficiency than if the enabler is not present. At 0.5 wt.-% and more, not only the encapsulation efficiency is improved but also the size of the microcapsules is in the preferred range.
The results also show that the optimal conditions for cross-linking the microcapsules with both glutaraldehyde and transglutaminase are met at an interfacial enabler concentration of 1.25 wt.-%, based on the total weight of the core composition. Under these particular conditions, there is no significant difference between the action of both cross-linking agents, as shown by the similar amount of measured extractable oil in heptane in both cases.
The low level of heptane extractable oil in sample 2.8 compared to the low encapsulation efficiency suggests that the microcapsules obtained with pimelic acid as enabler are less thermally stable that the microcapsules obtained with isophtalaldehyde as enabler. ” (see Specification, page 26).
Thus, the encapsulated composition of independent claim 1 is broad to the extent said encapsulated composition encompassed microcapsules that did not have high encapsulation efficiency (i.e., Example 2.8). As discussed above, the specification particularly indicated that the results from Tables 1 and 2 are specific to a combination of glutaraldehyde or transglutaminase with a particular interfacial enabler (i.e., isophtalaldehyde) at specific concentrations (i.e., 0.25 wt%-1.25 wt%). Thus, the results are concentration dependent. Furthermore, Example 2 also indicated that microcapsules compositions used is from Examples 1.1 and 1.2. As such, claim 1 is much broader than the microcapsules from Examples 1.1 and 1.2 and microcapsules used in Tables 1 and 2.
Applicant is noted that with any evidence of unexpected results, said evidence of unexpected results must be commensurate in scope with the claimed invention. Per MPEP §716.02(d):
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).”
For at least the reason above, the claimed invention remained obvious over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
Applicant argues:
“The secondary Ludvik reference is from the field of polymer particles in gel form (carbon aerogels, xerogels and cryogels) which is completely different from the claimed core- shell encapsulation of a benefit agent. In addition, the only disclosure in Ludvik relating to isophthalaldehyde and/or glutaraldehyde is that these aldehydes may be used with equal expectation of success as optional cross-linkers in a polymer formed by polymerization of a monomer component containing one or more phenolic compounds, which is not relevant to the claimed complex coacervate and interfacial enabler (no polymerization reaction takes place during capsule formation). There is no teaching in Ludvik, Duhoranimana or Yan 2, to any complex coacervate, or to any improvement in the efficiency of a complex coacervation that is due to employing isophthalaldehyde instead or in addition to the other disclosed aldehydes.” (Remarks, page 6, last paragraph to page 7).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, Ludvik was used for teaching and providing guidance on using a cyclic dialdehyde (isophthalaldehyde) as the crosslinking agent, as per Ludvik, aside from glutaraldehyde, cyclic or aromatic dialdehyde including isophthalaldehyde is also known to be a suitable dialdehyde crosslinker used in forming polymeric microparticles/microcapsules (Ludvik: [0065]-[0071]). Thus, Ludvik was not used for teaching the overall microparticles/microcapsules of Ludvik.
As such, it is noted that "[i]t is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements." In re Mouttet, 686 F.3d 1322, 1332, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012) (citing In re Etter, 756 F.2d 852, 859, 225 USPQ 1, 6 (Fed. Cir. 1985) (en banc)) ("Etter's assertions that Azure cannot be incorporated in Ambrosio are basically irrelevant, the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole."). See also In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981) ("The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art."); In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) ("[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review."); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) ("Combining the teachings of references does not involve an ability to combine their specific structures.").
As a result, for at least the reason discussed above, claims 1, 5-14, 16-20, 30, and 32-34 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
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, 5-14, 16-20, 30, and 32-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-12, 14-17, and 21-38 of copending Application No. 18293739 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending application ‘739 significant overlap with the subject matter of the instant claims i.e. encapsulated compositions containing microcapsules comprising a core and a shell surrounding the core, wherein the shell is by formed complex coacervate of a protein and a polysaccharide, and wherein the microcapsules further contains a cyclic dialdehyde.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending Application No. 18293739.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 05/05/2026 have been fully considered but they are not persuasive.
Applicant argues: “the present amendments and remarks remove all rejections, leaving the present rejection as the only rejection remaining. Therefore, Applicant respectfully requests withdrawal of this rejection. MPEP 804(I)(B)(1)(b)(i).” (Remarks, page 7).
In response, the Examiner disagrees. The claims in the copending application ‘739 are patentably indistinct of the claimed invention as the both sets of microcapsules are formed by complex coacervate of a protein and a polysaccharide, as well as, both sets of microcapsules contains the same cyclic dialdehyde.
Thus, per MPEP §804(I)(B)1), the provisional double patenting rejection should be made and maintained by the Examiner until Applicant overcomes the rejection by filing a terminal disclaimer.
As a result, for at least the reason discussed above, the provisional rejection of claims 1, 5-14, 16-20, 30, and 32-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-12, 14-17, and 21-38 of copending Application No. 18293739, is maintained for the reason of record, pending filing of a terminal disclaimer.
Conclusion
No claim is allowed.
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/DOAN T PHAN/Primary Examiner, Art Unit 1613
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