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
Applicant's election with traverse of Group I, claims 7, and 15-26, in the reply filed on 8/11/26 is acknowledged. The traversal is on the grounds that the common technical feature should not be characterized merely as an undifferentiated combination of two known hydrocolloids. The claimed inventions are linked by the use of a specifically proportioned rhamsan gum/gellan gum system as a soft-capsule shell gelling agent. The application demonstrates that this selected system, particularly at a rhamsan gum content of 80% by weight of the combined gums, provides a synergistic increase in shell strength while maintaining desirable elasticity.
Applicant further argues technical linkage among groups Group II expressly requires a soft-capsule shell comprising the gelling agent of claim 7. Claim 33 of Group III is expressly directed to preparing the soft-capsule shell of claim 27. Thus, the shell and method inventions are not unrelated applications of a generic composition; each is structurally and functionally tied to the same specifically proportioned shell-gelling system.
Hannetel does not remove the special technical feature Hannetel does not specifically disclose or exemplify the claimed rhamsan-gum-dominant binary system. Hannetel identifies rhamsan gum only as one member of an extensive list of optional additional gelling agents and separately provides a general ratio between gellan gum and one or more other gelling agents. Hannetel neither selects rhamsan gum from that list for combination with gellan gum, nor identifies a rhamsan-specific proportion, nor recognizes any synergistic shell-strength effect resulting from a rhamsan-gum-dominant ratio.
This is not found persuasive because it is noted that inventions listed as Groups I-III do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features as set forth in the previous Office Action.
Therefore, given that the Examiner has properly established that Groups I-III lack unity as set forth in the Office Action mailed 6/2/26, it is the Examiner's position that the restriction is proper.
Further, while rhamsan gum is one from a list of gelling agents, the fact remains that it would have been obvious to choose any gelling agent from the list, including rhamsan gum. Absent evidence to the contrary. Further, the mere fact that a reference teaches alternatives does not by itself render any particular alternative any less obvious. See Merck, 874 F.2d at 807; Susi, 440 F.2d at 445; Kubin, 561 F.3d at 1359.
Given that Hannetel discloses the gellant agent that overlaps the presently claimed gelling agent, including 50-95 wt% rhamsan, it therefore would be obvious to one of ordinary skill in the art, to use the gellant agent, which is both disclosed by (reference) and encompassed within the scope of the present claims and thereby arrive at the claimed invention.
Claim 7 is broadly to a gelling agent comprising rhamsan gum and gellan gum. The gelling agent as taught by the reference is the same gellant agent as claimed in claim 7 and therefore it would be expected that the gelling agent as taught by the reference can be used in a soft capsule gelling agent as claimed in claim 7.
Further, the data is not commensurate in scope with the scope of the claims.
The data only shows a gelling agent comprising rhamsan gum in a specific amount (60% and 80%) and gellan gum in a specific amount with a specific ratio fully hydrated while the claims broadly claim a gelling agent comprising rhamsan gum in an amount of 50%-95% and gellan gum of a total weight of the rhamsan gum and gellan gum in any hydrated amount.
Additionally, the data does not show using the amount of rhamsan gum at the lower end value and at the upper end value (i.e., 50 wt.% ; 95 wt%).
Further, the claims do not claim any specific synergistic shell strength effect property.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 7, 15-21 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hannetel et al (20090208568).
Hannetel, abstract, teaches the external liquid phase includes a gelling agent comprising gellan gum alone or in combination with another gelling agent, a filler, and a divalent metal sequestering agent.
Hannetel, paragraph 19 of the PGPUB, teaches gellan gum is a hydrocolloid which can be used as the sole gelling agent of the external liquid phase, or in combination with at least one other gelling agent. Other suitable gelling agents may be rhamsan gum.
Hannetel, paragraph 21 of the PGPUB, teaches when used in combination with at least another gelling agent, the weight ratio between gellan gum and the other gelling agent(s) is from 80/20 to 20/80, preferably 75/25 to 25/75, and even more preferably from 60/40 to 50/50.
As set forth in MPEP 2144.05, in the case where the claimed range “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).
Regarding claim 19, the rhamsan gum which is present in the amount of 80 wt% is substantially close to that of the instant claims that one of ordinary skill would have expected compositions that are in such close proportions to those in prior art to be prima facie obvious, and to have same properties. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not but are close enough that one skilled in the art would have expected them to have the same properties.
Regarding claim 20, Hannetal, paragraph 19 of the PGPUB, teaches suitable gellan gums are for example, but not limited to deacylated gellan gum.
Regarding claim 21, Hannetel, paragraph 19 of the PGPUB, teaches Kelogel gellum gum which is a high acyl gellan gum.
Regarding claim 24, Hannetel, paragraph 19 of the PGPUB, teaches gellan gum is a hydrocolloid which can be used as the sole gelling agent of the external liquid phase, or in combination with at least one other gelling agent. Other suitable gelling agents may be rhamsan gum.
The rhamsan gum as taught by the references is the same gum as claimed in claim 7 and therefore it would be expected that the rhamsan gum as taught by the references would have the same viscosity as claimed in claim 7.
Regarding claim 25, Hannetel, paragraph 19 of the PGPUB, teaches other suitable gelling agents may be alginates, agar, carragheenan, pectines, xanthan gum, Arabic gum, tara gum, ghatti gum, karaya gum, dextran.
Regarding claim 26, the reference does not teach gelatin.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hannetel et al (20090208568) as applied to claim 7 and further in view of Boetkjaer et al (20200339708).
Although the reference teaches gellan gums, the reference does not teach the gum to be partially deacylated gellan gum.
Boetkjaer teaches enzymatically modified gellan gum.
Boetkjaer, abstract, teaches a process for preparing partially deacylated gellan gum, the process comprising subjecting native or high acyl gellan gum to treatment with an esterase capable of partially deacylating gellan gum.
Boetkjaer, paragraph 24 of the PGPUB, teaches as appears from the schematic illustration below (FIG. 2), low-acyl gellan gum (LA) and high-acyl gellan gum (HA) are placed at either extreme on the scale of gel textures, whereas other gel-forming hydrocolloids are in between. Being able to create intermediately acylated gellan gum by the present process may provide the option of spanning the whole range of textures with one hydrocolloid and offer unique rheologic properties not available with the current portfolio of hydrocolloids.
It 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 to use a partially deacylating gellan gum as taught by Boetkjaer as the gellan gum as taught by the Hannetel to provide the option of spanning the whole range of textures with one hydrocolloid and offer unique rheologic properties not available with the current portfolio of hydrocolloids.
Regarding claim 23, the partially deacylating gellan gum as taught by Boetkjaer is the same gum as claimed in claim 22 and therefore it would be expected that the partially deacylating gellan gum as taught by the references would have the same viscosity as claimed in claim 23.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20080145505 teaches high performance gellan gums.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFANIE J COHEN whose telephone number is (571)270-5836. The examiner can normally be reached 10am- 6pm M-F.
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, Coris Fung can be reached at (571) 270-5713. 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.
/STEFANIE J COHEN/Examiner, Art Unit 1732 9/22/
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFANIE J COHEN whose telephone number is (571)270-5836. The examiner can normally be reached 10am- 6pm M-F.
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, Coris Fung can be reached at (571) 270-5713. 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.
/STEFANIE J COHEN/Examiner, Art Unit 1732 9/22/26
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