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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/12/2026 has been entered.
Applicants’ arguments, filed 02/12/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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, 3-8 and 13-24 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 8,574,624 B2, date of patent 11/05/2013) in view of Sydow et al. (US 2016/0136101 A1, publication date 05/19/2016) and Bezanson et al. (US 8,231,921 B2, date of patent 07/31/2012).
Regarding instant claims 1, 3, 4, 8, 13 14, 15 and 22, Li “provides the addition of highly inhibited starch filler to gelatin-free films and soft capsules” [abstract], wherein a soft capsule is defined “as a soft soluble container in which an active is enclosed” (i.e., instant claim 8) [col. 2, lines 17-18]. According to Li “the film and capsule will comprise from about 0.5 to 15 total dry weight percent, based on the total composition, of highly inhibited starch fillers” [col. 3, lines 26-28] and “the size of the highly inhibited starch filler ranges from about 1 um to about 50 um after cooking” [col. 2, lines 63-65]. Additionally, “The films and the soft capsules of the invention comprise at least one highly inhibited starch filler and at least one matrix starch” [col. 2, lines 33-35] wherein “[t]he matrix starch may also be chemically modified, including without limitation, … hydroxypropylated [starch]” [col. 3, lines 63-65]. “The films and the soft capsules composition of the invention may further include at least one plasticizer” such as glycerin [col. 4, lines 57-61]. Li further disclose that the soft capsules may comprise a blend of gums such as gellan gum and xanthan gum [col. 5, lines 7-12], and that a “blend of a high acyl gellan and a low acyl gellan gum may be used in any amount necessary to achieve the desired gel strengthening effect” [col. 5, lines 16-20].
Li differs from the instant claims insofar as it does not disclose the hot viscosity of the desired gellan gums and does not expressly disclose an enteric capsule.
Sydow “relates to gastro-resistant soft shell capsules having a capsule shell comprising high acyl gellan gum, at least one starch and at least one plasticizer” [abstract]. According to Sydow “the shell formulation and without the needed purified water used for processing for a soft shell capsule according to the present invention has preferably the following composition:
a) 5 to 8% (w/w), preferably 6 to 7% (w/w) high acyl gellan gum
b) 0 to 3% (w/w), preferably 0.2 to 2.0% (w/w) low acyl gellan gum
c) 50 to 70% (w/w), preferably 60 to 65% (w/w) of the starch
d) 20 to 40% (w/w), preferably 28 to 32% (w/w) of the plasticizer” [0023-0027]. Sydow discloses that suitable starches include hydroxypropylated starches [0035]. In the examples, Sydow discloses formulations including purified water (i.e., film forming compositions) (see [0055], Table 2; reproduced below).
PNG
media_image1.png
665
1185
media_image1.png
Greyscale
Finally, an important aspect of Sydow is that “the soft shell capsule may be free of any functional and protective coatings, e.g. an enteric-coating, which are often used for soft shell capsules according to the prior art” (i.e., enteric soft shell capsule without an enteric coating; instant claim 22) [0021]. To that end, Sydow discloses “Batch No. 3, batch No. 4 and batch No. 4 show gastro-resistant characteristics” [0062].
Bezanson discloses high performance gellan gums [title] which can be used as gelling agents in soft capsules [col. 7, lines 55-59]. According to Bezanson the high performance gellan gums provide greater gel strength than Kelcogel gellan gum [col. 4, lines 24-26]. Bezanson discloses a 1% solution of the inventive low acyl gellan gums have a viscosity of at least 25 cP (i.e., 25 mPa·s) [col. 5, lines 4-9]. Finally, Bezanson discloses that the viscosity of the gellan gum is related to the gelling performance [col. 10, lines 30-33].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the enteric capsule formulation of Sydow for the soft capsule formulations desired by Li. One would have been motivated to make this selection because Sydow discloses suitable formulations for soft capsules which comprise a starch matrix, e.g., hydroxypropylated starch, glycerol as a plasticizer, a blend of high acyl and low acyl gellan gums and no gelatine, as desired by Li.
Furthermore, given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Sydow. MPEP 2143 and 2144.06(I). Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the composition of Batch 4 of Table 2 to comprise up to 3% w/w low acyl gellan gum before the addition of water. Such a modification would have resulting in about 1.6% w/w low acyl gellan gum after the addition of water (i.e., 3% of 53.72% - the solid ingredients). Similarly it, would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have substituted the starch of Batch 4 for a hydroxypropylated starch.
With respect to the gellan gum, it would have been obvious to one of ordinary skill in the art, before the effective filling date, to have simply substituted the low acyl gellan gum disclosed by Sydow for the high performance gellan gum disclosed by Bezanson. One would have been motivated to do so because Bezanson disclosed the gellan gum provides the desirable effect of a stronger film. One would have had an expectation of success because Bezanson discloses the gellan gum can be used in the formulation of soft capsules and teaches the high performance gellan gum can be used to replace Kelcogel gellan gum. See MPEP 2143, Exemplary Rationale B.
Additionally, the instantly claimed range of gellan gum viscosity would have been obvious to one or ordinary skill in the art, before the effective filling date because "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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). One would have been motivated to optimize the viscosity of the of the gellan gum disclosed by Bezanson to modify the gelling performance. One would have had an expectation of success because Bezanson teaches a viscosity range and that the viscosity of the gellan gum relates to gelling performance.
With respect to the starch granules, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for starch granule size (10-50 microns) and amount of starch granules (1-3% w/w) overlap, respectively, with the prior art range for size (1-50 microns) and the range of 0.05-8% w/w starch granules (0.1-15% of the dry ingredients which comprise 53.72% w/w of the composition). Accordingly, a prima facie case of obviousness exists for both ranges.
Similarly, the instantly claimed ranges of 1.5-5% w/w gelling agent (gellan gum), 30-50% w/w starch, 10-25% w/w plasticizer, 35-55% w/w water, weight ratio of 0.03-0.2 gellan gum to starch (i.e., instant claims 3 and 13) and 0.2-5% w/w second gelling agent (i.e., instant claims 16 and 24) overlap with the prior art which teaches 1.6% w/w gelling agent (gellan gum), 33% w/w starch, 16% w/w plasticizer, 46.28% w/w water, a 0.048 gellan gum to starch weight ratio (i.e., 1.6 gellan gum to 33.16 starch) and 3.5% w/w high acyl gellan gum (i.e., second gelling agent). Therefore, a prima facie case of obviousness exists for each claimed range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated an enteric soft shell capsule prepared from a film forming composition comprising a first gelling agent of gellan gum, a hydroxypropylated starch, glycerol as a plasticizer (i.e., instant claims 4 and 14), water, starch granules and a second gelling agent. Wherein each component is present within the instantly claimed range. Wherein the viscosity of the gellan gum is within the instantly claimed range. Wherein the size of the starch granules is within the instantly claimed range. Wherein the composition does not comprise (i.e., not more than 2 wt% of ) acid-treated starch, acetate starch, a hydroxypropylated distarch phosphate, an acetylated starch and an acetylated distarch adipate. Wherein the weight ratio of gellan gum to starch is within the instantly claimed range.
Regarding instant claims 5, 16-18, 21 and 23-24, Li disclose that the soft capsules may comprise a blend of gums such as, for example, gellan gum and xanthan gum [col. 5, lines 7-12].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the xanthan gum of Li with the soft capsule formulations taught by Li, Sydow and Bezanson. One would have been motivated to, and had an expectation of success in making this combination because Li discloses the soft shell capsule may comprise a blend of both gellan gums and xanthan gums. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
"[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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case, given the disclosure of xanthan gum, a skilled artisan would have been motivated to optimize the amount of xanthan gum to optimize the gelling properties of the composition.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated an enteric soft shell capsules from the film forming composition taught by Li and Sydow, wherein the film forming composition further comprise xanthan gum within the instantly claimed ranges.
Regarding instant claims 6, 7, 19 and 20, "even 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.). In the present case, the prior art product appears to be the same or obvious as claimed, despite not teaching the claimed method, insofar as the soft capsule of the prior art is an enteric soft capsule formed from a composition comprising a hydroxypropylated starch, a plasticizer, gellan gum (as claimed), starch granules, water and less than 2% w/w of the acid treated starch, an acetate starch, distarches and acetylated starches.
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, 2-8 and 13-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US 12661406 B2 in view of Li et al. (US 8,574,624 B2, date of patent 11/05/2013), Sydow et al. (US 2016/0136101 A1, publication date 05/19/2016) and Bezanson et al. (US 8,231,921 B2, date of patent 07/31/2012).
The conflicting claims embrace a capsule [claim 10] and a film forming composition “comprising: (a) a first gelling agent; (b) starch; (c) a plasticizer; and (d) water” wherein “the starch is selected from the group consisting of: (i) a mixture of hydroxypropyl starch and an oxidized hydroxypropyl starch” (i.e., a hydroxypropylated starch) [claim 1]. Furthermore, the composition may comprise a second gelling agent, such as high acyl and low acyl gellan gum, in amounts from 0.1-5% w/w [claim 6]. Wherein the “the total content of the starch ranges from 35 to 40 wt %, the content of the plasticizer ranges from 10 to 30 wt %, and the content of the water ranges from 33 to 60 wt %” [claim 13]. Wherein the plasticizer may be glycerol [claim 5] and the composition may further comprise pullulan (i.e., second gelling agent according to instant claim 5) [claim 4].
The conflicting claims do not disclose starch granules, the hot viscosity of gellan gum and an enteric capsule.
Bezanson discloses high performance gellan gums [title] which can be used as gelling agents in soft capsules [col. 7, lines 55-59]. According to Bezanson the high performance gellan gums provide greater gel strength than Kelcogel gellan gum [col. 4, lines 24-26]. Bezanson discloses a 1% solution of the inventive low acyl gellan gums have a viscosity of at least 25 cP (i.e., 25 mPa·s) [col. 5, lines 4-9]. Finally, Bezanson discloses that the viscosity of the gellan gum is related to the gelling performance [col. 10, lines 30-33].
Li “provides the addition of highly inhibited starch filler to gelatin-free films and soft capsules” [abstract], which “provides improved film strength. Performance Such as capsule burst strength is improved” [col. 2, lines 1-3]. According to Li “the film and capsule will comprise from about 0.5 to 15 total dry weight percent, based on the total composition, of highly inhibited starch fillers” [col. 3, lines 26-28] and “the size of the highly inhibited starch filler ranges from about 1 um to about 50 um after cooking” [col. 2, lines 63-65].
Sydow discloses “gastro-resistant soft shell capsules having a capsule shell comprising high acyl gellan gum, at least one starch and at least one plasticizer, wherein the capsules fulfil pharmacopoeial disintegration tests characterizeing the capsules as gastro-resistant dosage forms” [abstract].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the gellan gums of Bezanson for the low acyl gellan gums desired by the conflicting claims because Bezanson discloses they are suitable for soft shell capsules.
Additionally, the instantly claimed range of gellan gum viscosity would have been obvious to one or ordinary skill in the art, before the effective filling date because "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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). One would have been motivated to optimize the viscosity of the of the gellan gum disclosed by Bezanson to modify the gelling performance. One would have had an expectation of success because Bezanson teaches a viscosity range and that the viscosity of the gellan gum relates to gelling performance.
With respect to the starch granules, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the highly inhibited starch filler (i.e., starch granules) of Li with the film forming composition disclosed by the conflicting claims for the improved strength disclosed by Li. One would have had an expectation of success because the starch granules of Li are specifically intended to be combined with film forming compositions for soft shell capsules. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined to the teachings of Sydow with the compositions taught by the conflicting claims to achieve the desirable effect of an enteric soft shell capsule. One would have had an expectation of success because Sydow discloses the enteric soft shell capsule should comprise high acyl gellan gum, starch, water and a plasticizer which are all embraced by the conflicting claims. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Finally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for the amount of each component and starch granule particle size overlap with the ranges taught by the conflicting claims and the prior art and so a prima facie case of obviousness exist for each range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have made an enteric soft shell capsule from a film forming composition comprising a gellan gum, a starch, a plasticizer, water and starch granules, wherein each component is present as instantly claimed.
Response to Arguments
1) On pages 9-10 of their Remarks, Applicant argues that the modifications to Obatake would not have produced an inherently enteric soft shell capsule and a skilled artisan would not have been motivated to make such medications because Obatake is directed to soft shell capsules with rapid disintegration.
This argument is moot in view of the new rejections set forth above.
2) On pages 10-11 of their Remarks, Applicant argues that Obatake in view of Bezanson and Muller fail to teach or suggest claim 1 as amended and that there is no motivation to modify Obatake based on Bezanson.
This argument is moot in view of the new rejections set forth above.
3) On pages 11-12 of their Remarks, Applicant argues that that "1 % gellan gum with a hot viscosity of at least about 25 cP at 90°C" in Bezanson is different from the claimed viscosity of "viscosity of the gellan gum solution ranging from 10-60 mPa·s obtained by dissolving l.5wt% gellan gum in water at 90°C for 30 minutes." And that such a disclosure is extremely broad and does not recognize the effect of viscosity on the capsule.
This argument is not persuasive. While the prior art may not disclose the exact viscosity recited in the instant claims, such a viscosity would have been obvious through routine optimization (e.g., see obviousness explanations in the rejections above). One would have been motivated to optimize the gellan gum viscosity because Bezanson links gelling performance and viscosity. Specifically, Bezanson discloses “The hot viscosity is believed to be related to the molecular weight, and hence gelling performance, of the
polysaccharide sample” [col. 10, lines 30-32].
4) On pages 12-13 of their Remarks, Applicant argues Muller is not analogous art. Furthermore, applicant argues that Muller does not teach the starch granules as instantly claimed.
This argument is moot in view of the new rejections set forth above.
5) On pages 14-15 of their Remarks, Applicant argues that the viscosity of the gellan gum provides unexpected results.
This argument is not persuasive. First, the instant specification as originally filed does not appear to directly acknowledge the viscosity of gellan gum as responsible for unexpected results. Instead, the specification points to the starch content as providing unexpected results (see page 11, para. 3, and page 16), and the claimed gellan gum as a suitable gelling agent for enteric soft capsules which provides strength to the films (see paragraph spanning pages 10 and 11).
Furthermore, overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant has not compared the results to the closes prior art and it is not clear that the results are truly unexpected.
(i) Applicant has not compared the allegedly unexpected results to the closest prior art. The closest prior art is the composition of Example 2 disclosed at Table II in column 9 of Li (see below). Example 11 of the instant specification (see Table 3, pages 18-20) does not clearly represent the Examples of Li because it only comprises one gellan gum.
PNG
media_image2.png
407
230
media_image2.png
Greyscale
(ii) The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (MPEP 716.02(b)). It is not clear from instant examples that the allegedly unexpected results are truly unexpected because the results have not been compared to the closest prior art.
6) On pages 16-17 of their Remarks, Applicant argues that the starches as instantly claimed unexpectedly produce an enteric soft capsule. Specifically, Applicant argues “that the addition of more than 2 wt% hydroxypropyl distarch phosphate inhibits the formation of enteric capsules” and “1 to 3 wt% starch granules with an average particle size of 10 to 50 microns achieves unexpected results in improving enteric capsule quality” [page 16].
This argument is not persuasive. Overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant has not compared the results to the closes prior art and it is not clear that the results are truly unexpected.
(i) Applicant has not compared the allegedly unexpected results to the closest prior art. The closest prior art is the composition of Example 2 disclosed at Table II in column 9 of Li (see below). Example 11 of the instant specification (see Table 3, pages 18-20) does not clearly represent the Examples of Li because it only comprises one gellan gum.
PNG
media_image2.png
407
230
media_image2.png
Greyscale
(ii) The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (MPEP 716.02(b)). It is not clear from instant examples that the allegedly unexpected results are truly unexpected because the results have not been compared to the closest prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
Prosecution Insights