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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) s 1-18, drawn to a method of orally administering a delivery system (comprising an outer capsule, an inner capsule and an active substance) to deliver the active substance to the intestine of a mammal .
Group II, claim(s) 19-35, drawn to a method of orally administering a delivery system (comprising an outer capsule, an inner capsule and a probiotic active substance) to deliver the probiotic active substance to the gut of a mammal.
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a method of orally administering a delivery system (comprising an outer capsule having an outer shell wall and an internal chamber, an inner capsule having an exterior shell wall and an inner compartment, the inner capsule being located in the internal chamber of the outer capsule, said inner capsule being acid resistant, an active substance present in the inner compartment of the inner capsule), this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Lynch (US 2019/0388345 A1). Lynch teaches ([0076], [0078] and Figure 1) a multi-chamber dosage form (see Figure 1) that has an outer capsule (defined by an outer capsule wall) and an inner capsule (defined by an inner capsule wall), the inner capsule being contained within the outer capsule and containing an active ingredient (which can be probiotic bacteria, anti-inflammatory agent or vitamins). Lynch further teaches ([0079] and [0080]) that both the outer and inner capsules of the multi-chamber dosage form may be enterically coated (i.e., both the outer and inner capsules are acid-resistant). Lynch also teaches ([0074]) that the multi-chamber dosage form may be taken orally.
During a telephone conversation with Ms. Caroline Smith (attorney for applicant) on December 18, 2025, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-35 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, on lines 3-4 and also on the 3rd line from the bottom, applicant need to change “a mammal,” to --- the mammal, ---. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: on line 2, applicant need to insert --- hard --- between “HPMC” and “capsule”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: applicant need to change “banned” to --- banded ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-6 and 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
(i) In claim 2, applicant recite that the outer capsule comprises an HPMC hard capsule. It is unclear to the Examiner what applicant mean by such limitation. Are applicant saying that the outer capsule can comprise other capsule(s) in addition to the HPMC hard capsule? Also, when applicant recite “outer capsule comprises an HPMC hard capsule”, are they saying that the outer capsule comprises the HPMC hard capsule within the outer capsule?
Instant 112 rejection can be overcome by changing “the outer capsule comprises an HPMC hard capsule.” in claim 2 to --- the outer capsule is an HPMC hard capsule. ---.
(ii) By the same reason, the limitations of claims 3 and 4 are also unclear, and instant 112 rejection can be overcome by changing “the inner capsule comprises a HPMC hard capsule with acid resistance.” in claim 3 to --- the inner capsule is a HPMC hard capsule with acid resistance. ---, and by changing “the inner capsule comprises a capsule comprising HPMC and gellan gum.” in claim 4 to --- the inner capsule is a capsule comprising HPMC and gellan gum. ---.
(iii) By the same reason, the limitations of claims 8 and 9 are also unclear, and instant 112 rejection can be overcome by changing “the outer capsule comprises a HPMC hard capsules with acid resistance.” in claim 8 to --- the outer capsule is a HPMC hard capsule with acid resistance. ---, and by changing “the outer capsule comprises a capsule comprising HPMC and gellan gum.” in claim 9 to --- the outer capsule is a capsule comprising HPMC and gellan gum. ---.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites that the inner capsule (of claim 1) comprises more than one inner capsule. Such limitation is confusing because it is unclear whether the claim is stating that the inner capsule contains more than one inner capsule within the inner capsule, or the outer capsule contains more than one inner capsule within the outer capsule. Instant rejection can be overcome by changing claim 14 to state --- wherein more than one inner capsules are located in the internal chamber of the outer capsule. ---.
Claim Rejections - 35 USC § 103
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.
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) 1-3, 7, 8, 11, 14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lynch (US 2019/0388345 A1).
Lynch teaches (abstract) a method for treating the gastro-intestinal system of a subject with prebiotic nutrients and probiotic bacteria. Lynch teaches ([0071]) that its invention is useful to nourish and supplement the microbiome of the human lower gastro-intestinal tract with desirable probiotic bacteria. Lynch further teaches ([0074]) a multi-chamber dosage form which can be taken orally, provided that the bacteria are enteric-coated or otherwise protected from the gastric juices of a subject’s body to thereby protect the viability of the probiotic bacteria until they reach the intestine of the subject. Thus, Lynch teaches a method of providing oral administration of an active substance (probiotic bacteria) to the intestine (the digestive tract) of the mammal.
With respect to instant delivery system, Lynch teaches (see Figure 1, [0076] and [0079]) its multi-chamber dosage form in a capsule form. As shown in Figure 1, an outer chamber defined by an outer chamber wall (instant outer capsule having an outer shell wall and an internal chamber) contains a prebiotic matrix material and an inner chamber defined by an inner chamber wall (instant inner capsule having an exterior shell wall and an inner compartment) containing probiotic bacteria (instant active substance present in the inner compartment of the inner capsule). In the figure, it is shown that the inner chamber is located within the outer chamber (thus teaching instant limitation “inner capsule being located in the internal chamber of the outer capsule”).
Lynch further teaches ([0079]-[0080]) that both chambers in its multi-chamber dosage form, may optionally be enteric-coated to protect the probiotic bacteria from the strong acids of the upper digestive tract, and the multi-chamber dosage form is formulated to dissolve at a predetermined gastrointestinal location. Based on Lynch’s teaching, it would be obvious to one skilled in the art to enterically coat both chambers (both instant outer and inner capsules) so as to protect the probiotic bacteria from the strong acids of the upper digestive tract so that the probiotic bacteria can be delivered to a predetermined gastrointestinal location. Thus, Lynch teaches instant limitation “said inner capsule being acid resistant” as recited in claim 1 as well as instant limitation “the outer capsule is an acid resistant capsule” as recited in claim 7.
Thus, Lynch renders obvious instant claims 1, 7 and 11.
With respect to instant claims 2, 3 and 8, Lynch teaches ([0159]) that its multi-chamber dosage form can be capsules where the capsule shell materials are selected from HPMC, pullulan or gelatin. Furthermore, Lynch teaches ([0079]) that the capsules may be hard or soft. It would have been obvious to one skilled in the art to make both inner and outer capsules in its multi-chamber dosage form to be HPMC hard capsules (with acid resistance as already discussed above). Thus, Lynch renders obvious instant claims 2, 3 and 8.
With respect to instant claim 14, Lynch teaches (Figure 3 and [0078]) that its multi-chamber dosage form can have an outer chamber that contains two inner chambers (i.e., instant more than one inner capsules). Thus, Lynch renders obvious instant claim 14.
With respect to instant claims 16-18, Lynch first teaches ([0003]) that one of the most important microbiomes is in the colon, and Lynch’s invention ([0035], [0065], [0071] and [0080]) provides a dosage form for the delivery of probiotic bacteria to the lower gastrointestinal tract to supplement and nourish the existing microbiome. Thus, it would be obvious to one skilled in the art to target the colon as the delivery site for the probiotic bacteria in Lynch’s inventive method. Furthermore, since Lynch teaches instant method of claim 1, the probiotic (instant active substance) would naturally be delivered to the colon in an amount which is at least 10 times greater (or at least 20 times greater or at least 30 times greater) than a capsule which dissolves in the stomach or small intestine as instantly recited in claims 16-18. Thus, Lynch renders obvious instant claims 16-18.
Claim(s) 4, 5, 9, 10, 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lynch (US 2019/0388345 A1) in view of Cade et al (US 2012/0288562 A1).
With respect to instant claims 4, 5, 9, 10, 12 and 13, Lynch does not teach instant gellan gum as its capsule material. Cade teaches ([0004]-[0005]) that the conventional way to provide acid-resistance to a capsule is by coating a non-acid resistant capsule with an enteric film. However, the methods of applying these coating solutions are complex, expensive, requires a high-level of expertise and may leave toxic solvent residues on the capsule after drying. Cade teaches (abstract and [0008]) a composition for a new acid-resistant hard capsule that has satisfactory mechanical properties and which can be manufactured by a cost-effective, environmentally friendly, healthy, safe and simple process. Cade’s acid-resistant hard capsule comprises an aqueous solvent, gellan gum and one or more water-soluble film-forming polymers, wherein the weight of the gellan gum to the one or more water-soluble film-forming polymers is between 4/100 to 15/100 (see [0009]). Cade further teaches ([0028]) that its preferred film-forming polymers are HPMC and gellan. In its Fig.1, Cade shows the dissolution profile of its hard capsule of Example 6 comprising gellan gum and HPMC in a 5/100 ratio (see also [0057] and [0063]) under different pH conditions. After 1 hour at pH 1.2, the Example 6 capsule shows negligible dissolution. After 2 hours at pH 1.2, there is less than 10% dissolution and at pH 6.8, the capsule completely dissolves in 2 hours. Cade teaches ([0063]) that this dissolution profile meets the definition of enteric-release hard capsules according to the Japanese Pharmacopeia 2. Thus, Cade’s gellan gum/HPMC hard capsule has acid-resistance comparable to an enteric coating. Based on Cade’s teaching, it would be obvious to one skilled in the art to use Cade’s gellan gum/HPMC composition in a weight ratio of 5/100 to provide acid-resistance to Lynch’s inner and outer chambers (instead of Lynch’s enteric coating) with a reasonable expectation of achieving the advantages as taught by Cade and listed above. Cade’s Example 6 capsule teaches instant gellan gum/HPMC capsule of claims 4, 5, 9, 10, 12 and 13. Thus, Lynch in view of Cade renders obvious instant claims 4, 5, 9, 10, 12 and 13.
With respect to instant claim 15, Lynch does not expressly teach that its inner chamber is banded. Cade teaches ([0019], [0044] and [0050]) that hard capsules are typically sealed or banded according to conventional techniques in order to avoid leakage of contained substances and to make the capsules tamper-proof. Based on Cade’s teaching, it would be obvious to one skilled in the art to band Lynch’s inner chamber in order to prevent leakage of the probiotic bacteria and to make it tamper-proof. Thus, Lynch in view of Cade renders obvious instant claim 15.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lynch (US 2019/0388345 A1) as applied to claim 2 above, and further in view of Cade et al (US 2012/0288562 A1) and Cade et al (US 2017/0087092 A1).
The Examiner established above (in relation to instant claim 2, from which claim 6 depends) that it would have been obvious to one skilled in the art to make both inner and outer capsules in Lynch’s multi-chamber dosage form to be HPMC hard capsules (with acid resistance as already discussed above). Lynch does not teach that its HPMC hard capsule comprises thermogelled HPMC. As evidenced by Cade’562 ([0013]-[0016]), it is known in the art that acid-resistant hard capsules are made by the process of dip-molding. As also evidenced by Cade’092 ([0007]), such process of dip-molding is conventionally known as thermogellation. It would be obvious to one skilled in the art to make Lynch’s HPMC hard capsules acid-resistant by dip-molding process with a reasonable expectation of success. Thus, Lynch further in view of Cade’562 and Cade’092 render obvious instant claim 6.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
January 10, 2026