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 .
DETAILED ACTION
Election/Restriction
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
3. Group I: Claims 1-12, 14, drawn to ‘ A non -gelatin soft capsule product’, classified in CPC A23)10/30.
4. Group II: Claims 15-20 drawn to ‘ A process for manufacturing the non-gelatin soft capsule”, classified in CPC A61K 9/4833.
5. The inventions are distinct, each from the other because of the following reasons:
6. Inventions group II and group I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case ‘A non -gelatin soft capsule product’ the could be made by a materially different process such as ‘spherification technique’ by using hydrocolloid and it consists of a controlled gelification of a liquid which forms spheres when submerged in a bath. In the instance case, the method can be used to make another and materially different product e.g. any encapsulated pharmaceutical product for oral, local application and also any encapsulated beauty product for local application.
7. Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply:
8. The inventions have acquired a separate status in the art:
a. In view of their different classification;
b. Due to their recognized divergent subject matter;
9. The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
10. The prior art applicable to one invention would not likely be applicable to another invention;
11. The inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
12. Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
13. The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention.
14. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
15. 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(a) of the other invention.
16. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
17. The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
18. In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b).
Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
19. During a telephone conversation with Atty. Mr. Demian Barbas , Reg. No. 65,750 (Tel. No.: 1-514-847-4867) on 6/08/2026, a provisional election was made without traverse to prosecute Group I noted above, claims 1-14 and withdrawing method claims of Group II claims 15-20 from further consideration [37 CFR 1.142 (b)], and as being drawn to a non-elected invention.
Status of the application
20. Claims 1-12, 14-20 are pending in this office action.
Claims 15-20 are withdrawn due to Election/Restriction on phone as mentioned above.
Claims 1-12, 14 have been rejected.
Claim Objections
21. Claim 13 objected to because of the following informalities: It is to be noted that claim 13 is missing. Therefore, applicants should amend to provide a status of claim 13 or can renumber claims after claim 12 accordingly. Examiner has not considered claim 13 in this office action. Appropriate correction is required.
Claim Rejections - 35 USC § 103
22a. 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 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.
22b. The following is a quotation of 35 U.S.C. 108, which forms the basis for all obviousness rejections set forth in this Office action.
(a) A patent may not be obtained though the invention is not identically
disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
22c. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966), that are applied for establishing a background for
determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims
at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
23. Claim(s) 1-7, are rejected under pre- AIA 35 U.S.C. 103(a) as being unpatentable over Tanner et al. USPN 6582727 in view of Harel et al. US 2012/0058195 in view of Hausmanns et al. US 2004/0087669 in view of Young et al. (KR 2009/0130580 A) and in view of Wittwer et al. USPN 4655840 and in view of Ballard et al. (CN 1791782 A) and as evidenced by NPL agar vs agar- agar (Page 1).
24. Regarding claims 1, 2, 4, 6, 7, Tanner et al. discloses that a soft capsule composition is made in the form of a film ( at least in col 6 lines 35-37, col 7 lines 10-12) and two films are fused to seal by encapsulating liquid fill material (col 7 lines 13-18, col 6 lines 50-52) having the property to encapsulate liquid also ( Abstract, col 13 lines 25- 35; e.g. col 13 lines 29-30, hydrophilic liquid i.e. water) and soft capsule comprises soft dry shell which comprises hydrocolloid, starch, plasticizer to meet claim 1 and further hydrocolloid e.g. carrageenan (at least in col 8 lines 62-65 and col 12 lines 5-10) to meet claim 2, plasticizer ( col 8 lines 10-20) and plasticizer can be glycerin, or sorbitol (col 8 lines 22-26) as claimed in claim 4 and having pH 7-10 (col 9 lines 56-58) as claimed in claim 7, and it is non-gelatin soft capsule, however having greater stability when exposed to elevated humidity and temperature than capsule made with gelatin (col 10 lines 35-40) to make liquid —fill material encapsulated soft capsule product.
Regarding the claim limitation of “at least 20% water”, it is to be noted that Tanner et al. discloses “ encapsulate liquid also ( Abstract, col 13 lines 25- 35; e.g. col 13 lines 29-30, hydrophilic liquid i.e. water). This can be any amount of water including claimed “at least 20% water” as claimed in amended claim 1. It shows prima facie case of obviousness according to MPEP 2144.05. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Tanner et al. is silent about “an agar -agar coating to a chewable capsule
composition as claimed in the amended claim 1.
It is to be noted that Tanner’s disclosure is broad and Tanner’s capsule
does not exclude the chewable property and it can be chewable capsule also. However, Young et al. discloses that agar (agar) can be used to coat a soft capsule having chewable property (at least in Abstract and paragraph above claim 12 of Young et al.). It is known that agar (-agar) are similar as evidenced by NPL agar vs agar- agar (Page 1).
Wittwer et al. discloses that a water-soluble polymer e.g., agar -agar
(food grade) can be used as a coating film forming material which is equivalent and a substitute for gelatin film forming material and can be used to make non-gelatin capsule to be used in food or pharmaceutical industry (Col 16 lines 60-62, 63, 65-67, col 17 lines 1-5). It is known that gelatin is animal origin which means one of ordinary skill in the art can select agar -agar with a reasonable expectation of success to consider substitute of gelatin in order to make non animal (i.e., veg) product.
One of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify Tanner et al. to include the teaching of Young et al. to make agar -agar coated soft capsule having chewable property (at least in Abstract and paragraph above claim 12 of Young et al.) and the teaching of Wittwer et al. can be used to incorporate food grade agar-agar which can be used as a coating film forming material which is equivalent to gelatin and is considered to make non-gelatin capsule as disclosed by Wittwer et al. (At least in to be used in food or pharmaceutical industry Col 16 lines 60-62, 63, 65-67, col 17 lines 1-5 and col 44 lines 21-22).
It is to be noted that, even if Young et al. discloses gelatin, agar (agar) in
the chewable capsule composition, however, Young et al. is secondary prior art and Young discloses additionally that agar (agar) can be used to coat a soft capsule having chewable property (at least in Abstract and paragraph above claim 12 of Young et al.) and gelatin can be substituted with agar-agar to make non-gelatin capsule as desired as disclosed by Wittwer et al. Therefore, Young is combinable.
Regarding bite size, firstly, Tanner discloses the dimensionally stable film
having thickness “at least about 0.01 inches” (at least on col 10 line 65). It is to be noted that and as it is known that bite size is the size comfortable to bite and it is within the skill of one of ordinary skill in the art to make the size comfortable to bite for the end user use.
However, (additionally), more specifically, Tanner et al. in view of Young
et al. and Wittwer et al. are specifically silent about the claimed membrane thickness range value of 0.9 to 2 mm as claimed in amended claim 1.
Ballard et al. discloses that gel film from hydrocolloid (at least in
claim 2 of Ballard et al. used to prepare capsule having thickness of the dry film for soft capsule is 0.5-3.0 mm (at least on page 5, line 5). It shows prima facie case of obviousness according to MPEP 2144.05. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
One of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify Tanner in view of Young et al. to make gel film from hydrocolloid (at least in claim 2 of Ballard et al. to be used to prepare soft capsule having thickness 0.5-3.0 mm (at least on page 5 paragraph 5) in order to provide proper protection of the coated materials in the capsule. Therefore, it is within the skill of one of ordinary skill in the art to optimize the thickness from within the disclosed range amounts which will meet the claimed range amount to provide the claimed property and size including the bite size or sip size as claimed in claim 2.
Absent showing of unexpected results, the specific amount of thickness is not considered to confer patentability to the claims. As the size , taste, texture are variables that can be modified, among others, by adjusting the amount thickness , the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of size in Tanner et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desred bite size of a semi-solid ir desired sip size of liquid material with good taste and texture etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Tanner et al. in view of Young et al. and Wittwer et al.
are silent about phospholipid in the composition as claimed in claim 1 and phospholipid is lecithin as claimed in claim 6.
Harel et al. discloses that lecithin or modified lecithin (phospholipid)
([0035]) is used in such a composition in order to make emulsifier rich inner layer and fat is added e.g., including wax ([0029]) in order to make solid-fat —rich outer layer ([0034]) in order to have the benefits if having emulsifier rich inner layer coat and the double layer coat serves as substantial barrier to moisture and protecting the core bioactive substance and rupture resistant ([0046]). It is also to be noted that lecithin is an emulsifier also. It is known that lipid, wax is water resistant. Therefore, it can make a water barrier layer and lecithin can also emulsify as is also evidenced by applicant’s own specification (in PGPUB [0054], Emulsified hydrocolloid). Therefore, it would have been obvious that the disclosed encapsulating capsule can perform the function to incorporate hydrophilic material.
One of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify Tanner et al. in view of Young et al. and Wittwer et al. to include the teaching of Harel et al. to incorporate lecithin or modified lecithin (phospholipid) ([O035]) is used in such a composition in order to make emulsifier rich inner layer and fat is added e.g. including wax ([0029]) in order to make solid-fat —rich outer layer ([0034]) in order to have the benefits if having emulsifier rich inner layer coat and the double layer coat serves as substantial barrier to moisture and protecting the core bioactive substance ([0046)).
Regarding “heat-sealable’, it is to be noted that Tanner et al. discloses that
the film may be stretched and finished capsule exhibit greater stability when exposed to elevated humidity and temperature than capsule made using gelatin ( col 10 lines 35- 40) and it is blow molded at a temperature at which the two oppose films, in contact with each other, will blend at their contact interface (fusion temperature) to become one, indistinguishable and inseparable structure (col 11 lines 4-9) which is interpreted as heat-sealable as claimed in claim 1.
Tanner et al. in view of Young et al. and Wittwer et al. Ballard et al. and
Harel et al. are silent about thermo-formable membrane as claimed in claim 1.
Hausmanns et al. discloses that soft capsule used for food products
(Abstract) can be made as sheets, films with greatly increased strength ([0036]) by thermoforming process ([0036]) where glycerol or other polyols can be used as plasticizers ([0038]) by combining starch e.g. starches from chestnuts, corn ([0088], [0089]) with glucan (water insoluble) ([(0040]) and thermoforming process is a process where starch of many types is thermoformed in a suitable processing method , preferably, a press or an extruder to give a sheet or film and then further processed to make capsule ([0029)). Therefore, corn starch can be effective in presence of glycerol ([0038], [0088], [0089]). Therefore, it meets corn starch, chestnut starch of claim 3. It is also to be noted that claim 3 broadly claims ‘corn starch’. Tanner et al. discloses “modified corn starch” ( col 8 lines 20-25) as discussed above.
Therefore, it is understood that the components e.g., native starch, glucan,
plasticizer containing such components in the composition can make the composition thermoformable.
One of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify Tanner et al. in view of Young et al. and Wittwer et al. and Harelet et al. to include the teaching of Hausmanns et al. to use the mixtures of the components to make the composition suitable for thermoformable process to make sheets and soft capsule ([0029]) for the desired use.
25. Regarding claim 3, Tanner et al. discloses that starch includes broadly
many starches including modified corn starch ( col 6 lines 45-47, col 8 lines 20-24) and also the composition with carrageenan further includes maltodextrin (col 8 lines 56-58) in order to reach desired specification (col 8 lines 55-60). Hausmanns et al. discloses corn starch can be effective in presence of glycerol ([0038], [0088], [0089]).
26. Regarding claim 5, Tanner et al. also discloses that the composition with carrageenan further includes sugar (col 8 lines 55-60) in order to reach desired specification (col 8 lines 55-60).
Young et al. discloses sugar e.g., sucrose is used in chewable capsule
composition (in Young et al., Abstract and (at least in Abstract, page 3, Under “Description-of-Embodiment) in order to include the teaching Young et al. to incorporate sugar as an additive to provide sweetness property of the product (in Young et al., Abstract and page 3 under Description-Of-Embodiments).
27. Claim 8 is rejected under pre-AlA 35 U.S.C. 103(a) as being
unpatentable over Tanner et al. USPN 6582727 in view of Harel et al. US 2012/0058195 in view of Hausmanns et al. US 2004/0087669 in view of Young et al. (KR 2009/0130580 A) and (additionally) in view of Wittwer et al. USPN 4655840 and in view of Ballard et al. (CN 1791782 A) as applied to claim 1 and further in view of Xie et al. WO 2011/014942 A1.
28. Regarding claim 8, Harel et al. discloses that lecithin or modified lecithin
(phospholipid) ([0035]) is used in such a composition.
It is known that lecithin is also a softener. However, as because disclosed
lecithin is used to address the phospholipid source, therefore, additionally Xie et al. is used as secondary prior art to address further softening agent in such a composition.
Xie et al. discloses that lecithin can be used as softening, anti-caking
agent and softening agent (in claim 14 of Xie et al.).
However, Xie et al. discloses that anti-caking agent, softening agents can include lecithin, oils, fats or combinations thereof (In claim 14 of Xie et al.) which reads on “further anti-caking agent in addition to (i.e. ‘combination thereof’) phospholipid lecithin. Therefore, one of ordinary skill in the art can include more than one softening agent in addition to lecithin e.g., oils as “mixtures thereof can be used as softening, anti- caking agent and softening agent (in claim 14 of Xie et al.).
One of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify Tanner et al. in view of Young et al. and Harel et al. in view of Harrel to include the teaching of Xie et al. who discloses that oils can be used as to serve as softening, anti-caking agent (in claim 14 of Xie et al.) in such a composition.
29. Claims 9, 12 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Tanner et al. USPN 6582727 in view of Harel et al. US 2012/0058195 in view of Hausmanns et al. US 2004/0087669 in view of Young et al. (KR 2009/0130580 A) and (additionally) in view of Wittwer et al. USPN 4655840 and in view of Ballard et al. (CN 1791782 A) as applied to claim 1 and further in view of Fonkwe et al. USPN 6949256.
30. Regarding claim 9, Tanner et al. in view of Young et al. and Harel et al. and Hausmanns et al. are silent about specific viscosity of the composition.
It is to be noted that claim 1 is broad and Fonkwe et al. discloses (col 5
lines 35- 47) to make final viscosity of such a composition can be in the desired disclosed range including 100 cP to 1200 cP and it can be modified to desired modification to achieve desired physical properties of final gel or film (col 5 lines 35-47) and modifications can be made which do not depart from the spirit of the invention (col 12 lines 55-60) which overlaps 1 to 10 Pa.s. (1 Pa.s=1000 mPa:s. =1000cP).Fonkwe et al. discloses (col 5 lines 35-47) to make final viscosity of such a composition can be in the desired disclosed range including 100 cP to 1200 cP and it can be modified to desired modification to achieve desired physical properties of final gel or film (col 5 lines 35-47) and modifications can be made which do not depart from the spirit of the invention (col 12 lines 55-60) which overlaps 1 to 10 Pa.s. (1 Pa.s=1000 mPa:s. =1000cP).
Therefore, it is within the skill of one of ordinary skill in the art to optimize
the specific viscosity value at the specific condition. One of ordinary skill in the art can modify the viscosity value by optimizing the amount of hydrocolloid which is viscosity agents as disclosed by Fonkwe et al. (col 5 lines 35-47) to make final viscosity in the desired disclosed range including 100 cP to 1200 cP to modify the physical properties of final gel or film (col 5 lines 37-40) and modifications can be made which do not depart from the spirit of the invention (col 12 lines 55-60) which overlaps 1 to 10 Pas. (1 Pa. s=1000 mPa.s. =1000cP) of claim 9.
One of ordinary skill in the art would have been motivated to modify
Tanner et al. in view of Young et al. and Harel et al. in view of Hausmanns et al. to include the teaching of Fonkwe et al. to make final viscosity in the desired disclosed range including 100 cP to 1200 cP to modify the physical properties of final gel or film (col 5 lines 37-40).
It is to be noted that the viscosity depends on specific percent amounts of
hydrocolloid mixture and percent amount of aqueous solution and the temperature at which it is measured i.e., viscosity is temperature dependent.
Also, as discussed above, Fonkwe et al. discloses that modifications can be made which do not depart from the spirit of the invention (col 12 lines 55-60). Therefore, it is within the skill of the one of ordinary skill in the art to optimize the viscosity in order to have desired final product of desired physical property.
Absent showing of unexpected results, the specific amount of viscosity is
not considered to confer patentability to the claims. As the viscosity is variable that can be modified, among others, by adjusting the amount of viscosifying agent (hydrocolloid mixture), liquid (water), type of viscosifying agent and temperature etc. (liquid), the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of viscosity in modified Tanner et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g., desired final viscosity of the membrane. (In re Boesch, 617 F.2d. 272, 205 USPQ
215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
31. Regarding claim 12, it is to be noted that the claimed elasticity
value which depends on viscosity etc. and therefore, the hardness, is not specifically disclosed by Fonkwe et al.
Therefore, it is within the skill of one of ordinary skill in the art can optimize
the physical parameters like hardness etc. of the capsule. The precise elasticity value which depends on viscosity etc. would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the percent value of elasticity in Fonkwe et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g., strength and flexibility of the membrane etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
32. Claims 10, 11 are rejected under 35 U.S.C. 103 as being
unpatentable over Tanner et al. USPN 6582727 in view of Harel et al. US 2012/0058195 in view of Hausmanns et al. US 2004/0087669 in view of Young et al. (KR 2009/0130580 A) and in view of Wittwer et al. USPN 4655840 and in view of Ballard et al. (CN 1791782 A) as applied to claim 1 and further in view of West et al. WO 2004/009456.
33. Regarding claims 10,11, Tanner et al. in view of Young et al.
and Harel et al. and Hausmanns et al. are silent about internal volume of such a capsule.
West et al. discloses that the volume of such a capsule can be 2.5 ml to
50 ml (in claim 11 of West et al.).
One of ordinary skill in the art would have been motivated to modify
Tanner et al. in view of Young et al. (and Oshino et al.) and Harel et al. and Hausmanns et al. to include the teaching of West et al. to make the capsule having internal volume from within the range amounts of 2.5 to 50 ml which meets claimed range between 1 to 10 ml. of claim 22 in order to have desired internal volume of choice for intended use.
34. Regarding claim 11, e.g., the weight depends on the individual
component and it varies. For example, for water, 1 ml= 1 gm. Therefore, it is within the skill of one of ordinary skill in the art to calculate the weight of a particular substance from the formula D=Mv to be encapsulated into the capsule which can be, e.g., water or close density water like component or any component having the corresponding weight also.
35. Claim 14 is rejected under pre-AlA 35 U.S.C. 103(a) as being
unpatentable over Tanner et al. USPN 6582727 in view of Harel et al. US 2012/0058195 in view of Hausmanns et al. US 2004/0087669 in view of Young et al. (KR 2009/0130580 A) and (additionally) in view of Wittwer et al. USPN 4655840 and in view of Ballard et al. (CN 1791782 A) as applied to claim 1 and further in view of Yang et al. US 2009/0123559 and (alternatively), in view of West et al. US 2003/0124225.
36. Regarding claim 14, Tanner et al. discloses that any type of liquid
material can be encapsulated in such a soft capsule (in Tanner et al. at least in col 13, lines 25-38).
Tanner et al. in view of Young et al. (and Oshino et al.) and Harel et al. are
silent about specific liquid material as claimed in claim 38.
Yang et al. discloses that honey refined extract can be encapsulated
within the soft capsule to use as oral liquid preparation for oral nutritional/medicinal use ([0016)).
One of ordinary skill in the art would have been motivated to modify
Tanner et al. in view of Young et al., Oshino et al. and Harel et al. and Hausmanns et al. to include the teaching of Yang et al. discloses that honey refined extract can be encapsulated within the soft capsule to use as oral liquid preparation for oral nutritional/medicinal use ([0016]).
(Alternatively), West et al. discloses that alcohol containing materials can
be encapsulated in the soft capsule also ([0041]) in a special type of resilient gelatin soft capsule ([(0041]). West et al. also discloses that conventional gelatin capsule is not compatible to encapsulate alcohol liquid filling product ([0012]). Therefore, even if West discloses that special type of gelatin is used to encapsulate alcohol liquid in modified gelatin soft capsule, however, this teaching can be used by one of ordinary skill in the art to consider liquid-fill non-gelatin capsule to fill the alcohol liquid product in the soft gel capsule in order to have desired alcohol in small amounts to be required as per customer's need.
One of ordinary skill in the art would have been motivated to modify
Tanner et al. in view of Young et al. (and Oshino et al.) and Harel et al. and Hausmanns et al. to include the teaching of discloses that conventional gelatin capsule is not compatible to encapsulate alcohol liquid filling product ([0012]) in order to have soft gel capsule in order to have desired alcohol in small amounts to be required as per customer's need.
Conclusion
37. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful,
examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights