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 .
Status of Claims
Claims 1-5 & 8 are pending and examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, Claim 1 already recites that the absorbent material comprises carboxymethyl cellulose, which is a type of modified cellulose. Thus the recitation of “modified cellulose” in Claim 8 is broader than what was already recited in Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kitzul (US 2,931,353) in view of Nielsen et al. (US 6,569,081).
Re Claims 1 & 8, Kitzul discloses an absorbent insert ostomy device (plug 10) for insertion through an ostomy of a human being, the absorbent insert ostomy device being configured to absorb intestinal fluid and waste inside the intestines of the human being, the absorbent insert ostomy device comprising:
an elongated body extending along a longitudinal direction of the absorbent insert ostomy device and comprising a stoma end and an oral end spaced from the stoma end along the longitudinal direction, wherein the elongated body comprises an absorbent material (col. 2 line 8);
a withdrawer (cord 11 and/or any of button 12, sleeve 13, and pad 15) attached to the stoma end of the elongated body; and
wherein the elongated body comprising the absorbent material is further configured to be pulled out of the intestine of the human being by the withdrawer (implied by col. 1 lines 38-40).
Kitzul does not disclose that the elongated body is expandable, wherein the absorbent material comprises carboxymethyl cellulose or modified cellulose, that the device comprises a compress configured to maintain the expandable elongated body in a compressed state, comprising a first diameter along the longitudinal direction, prior to insertion of the absorbent insert ostomy device through the ostomy of the human being; wherein the expandable elongated body is configured to expand radially to a non- compressed state, comprising a second diameter along the longitudinal direction, when released from the compress upon insertion into an intestine of the human being through the ostomy; wherein the second diameter is larger than the first diameter.
Nielsen discloses a stomal plug comprising a cover (e.g., 14 in Fig. 7, col. 8 lines 10-19, “shape retaining cover or outer layer 14 which is sensitive to heat and/or moisture such that it ceases to hold the body in the compressed state”) enclosing an absorbent material to keep the stomal plug in a compressed state and allowing the stomal plug to expand after insertion into the stoma (e.g., Figs. 7-8 and col. 8 lines 10-19), wherein the absorbent material can be formed of carboxymethyl cellulose (col. 5 lines 24-39). It would have been obvious to one skilled in the art at the time of filing to add in the cover and incorporate the carboxymethyl cellulose as disclosed in Nielsen because this allows for easier insertion of the plug while reducing leakage from the stoma (due to the expanded size of the plug to seal up gaps between the plug and the intestine). Additionally, the selection of a material suitable for its intended purposes (i.e., including an absorbent material known to be suitable for absorbing liquids in a stoma) establishes a prima facie case of obviousness (MPEP 2144.07).
Re Claim 2, Kitzul and Nielsen combine to disclose claim 1, wherein the expandable elongated body changes from being rigid to being flexible when the expandable elongated body expands radially from the compressed state to the non-compressed state (since carboxymethyl cellulose turns gel-like upon absorbing fluid, it necessarily gives the plug more flexibility).
Re Claim 3, Kitzul and Nielsen combine to disclose claim 1, and the combination discloses wherein the absorbent material is biodegradable (because carboxymethyl cellulose is biodegradable).
Re Claim 4, Kitzul and Nielsen combine to disclose claim 1, but neither discloses wherein the absorbent material comprises at least 50% by weight of carboxymethyl cellulose compared to a total weight of the expandable elongated body. However, given the well-recognized high absorption capability of carboxymethyl cellulose, one skilled in the art may find it desirable to make carboxymethyl cellulose the major component in the stomal plug so as to give the plug greater absorption at a given dry weight and size.
Re Claim 5, Kitzul and Nielsen combine to disclose claim 1, Kitzul also discloses wherein the first diameter is 1.75 cm or less (col. 2 lines 9-10 “diameter which may be one-half inch”). Neither Kitzul nor Nielsen discloses that the second diameter is at least 2 cm or wherein the expandable elongated body in the non-compressed state comprises a length along the longitudinal direction of at least 20 cm, and wherein the absorbent material comprises an absorption capacity of at least 50 ml. However, the claimed dimensions and property are dependent on the medical needs of the patient, e.g., the lumen size of the patient’s intestine and the volume of fluid present in the patient’s intestine. Therefore a medical professional, one of ordinary skill in the art in the field of stoma care, would have the knowledge and desire to find a stoma plug of suitable size and absorption capacity so as to prevent leakage from the stoma.
Conclusion
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/SUSAN S SU/Primary Examiner, Art Unit 3781 25 July 2026
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