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 without traverse of Group I, Clm 1-5 and 12-22 in the reply filed on 29 July 2026 is acknowledged.
Claim Objections
Applicant is advised that should claim(s) 2 and 22 be found allowable, claim(s) 2 and 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 2, 22, and dependents is/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.
Regarding Claims 2 and 22, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 2 recites the broad recitation “at least 20 grams”, and the claim also recites “at least 30 grams” or “at least 40 grams” which is the narrower statement of the range/limitation (i.e. “at least 20 grams” is a range of 20 grams with no definite upper bound, whereas “at least 30 grams” is a narrower range of 30 grams with no definite upper bound, and “at least 40 grams” is an even narrower range of 40 grams with definite upper bound). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-5, 12-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 4,285,814 (“Morgan”).
Regarding Claim 1, Morgan discloses a tissue trap (32) for use with a fluid management system (see generally Fig. 1 – note that the fluid management system is not positively required by the claims) to collect a liquid outflow containing a tissue debris produced by a tissue resection system, the tissue trap comprising:
A tissue trap body (40, 42) configured for positioning withing a fluid collection sac (see generally 22 - note that the sac is not positively required) of the fluid management system through an opening of a threaded fitting of the fluid collection sac (in the instant case while the opening of 22 is not illustrated as threaded this component is not positively recited by the claim), the tissue trap body having a bag opening (20) with a trap washer (46) located about the bag opening (see Fig. 1), such that, when the tissue trap body is positioned within the fluid collection sac (see generally Fig. 1), the trap washer is configured for positioning about the threaded fitting to form a seal thereagainst when a locking cap (generally 26 – not positively recited, whereby the bag could be used with threaded caps in contrast to the specific type of 26) is secured to the threaded fitting to permit liquid outflow to enter the tissue trap and fluid collection sac (see generally Fig. 1 – i.e. the circumferential flange of 46 – see Fig. 1 – is configured to engage with any suitable circular opening including both unthreaded – see Fig. 1 – and threaded configurations without modification);
wherein a wall material of the tissue trap body comprises a liquid permeable wall portion (44; Col. 2, Ln. 1-6) such that when a liquid and a resected tissue enters the tissue trap body and fluid collection sac, the liquid passes through the liquid permeable wall portion into the fluid collection sac while the tissue debris remains within the tissue trap body (Abstract; i.e. fluid enters 32 passes through the bag) , wherein the tissue trap body containing the tissue debris is configured for removal from the fluid collection sac through the threaded fitting while the fluid collection sac remains in place (i.e. the cap can be removed thereby allowing the bag to be removed from 22).
Regarding Claim 3, Morgan discloses the liquid permeable wall portion comprises a material selected from a group consisting of a cloth, a mesh, a screen or a composite material (Col. 2, Ln. 1-6).
Regarding Claim 4, Morgan discloses an entirety of the wall material (wherein 44 is considered to be extensive of the “wall material” of the tissue trap body is liquid permeable (Col. 2, Ln. 1-6).
Regarding Claim 5, Morgan discloses the liquid permeable wall portion is located at a lower end of the tissue trap body such that the liquid drains outflow from the lower end (see Fig. 1).
Regarding Claim 12, in Morgan the trap washer is dimensioned to engage a top of the threaded fitting (see generally Fig. 1 – note that the threaded fitting is not required and while the fitting 16 of Morgan is not threaded the trap washer, per se, is suitable for interfacing any suitably dimensioned circular fitting in a sealing manner including fittings shown in Fig. 1 or alternatively designed threaded fittings and caps without modification to the trap washer or trap, per se).
Regarding Claim 13, Examiner notes that the locking cap is not positively required by the claim and while the cap of Morgan is shown being of a bayonet (see Fig. 2) type engagement the trap washer of Morgan is suited to pair with any suitably dimensioned cap and fitting arrangement including alternatively configured threaded engagements).
Regarding Claim 14, Examiner again notes that the locking cap is not positively required, but in Morgan the locking cap includes a fitting (32) configured to receive a distal end of an outflow tubing coupled to a tissue resection system.
Regarding Claim 15, in the instant case while Morgan does not disclose a “luer fitting” inasmuch as the cap is not positively required by the claim such a recitation toward a luer fitting is not required as it has no effect on the physical structure of the trap itself. The claimed invention only necessitates a trap washer which is constructed of a manner which permits it to be secured to such a cap without modification to the trap. Such a washer is provided by Morgan wherein the trap of Morgan can be used with other devices/caps by the ordinary artisan without any specific modification to then trap per se.
Regarding Claim 16, Morgan discloses the bag opening comprises an open end of the tissue trap body, and the trap washer is located about the open end (see Fig. 1).
Regarding Claim 17, Morgan discloses the liquid permeable wall portion comprises a foldable material configured to be collapsed for insertion through the opening of the threaded fitting (see Fig. 1; Col. 2, Ln. 1-9), i.e. the bag of Morgan is made of a flexible cloth or plastic mesh material which can be folded in any of a variety of manners to assist in its insertion into a corresponding “sac”).
Regarding Claim 18, Morgan discloses the wall material of the tissue trap body further comprises a remainder portion (40 – wherein the wall is considered to be the combination of 40 and 44) that is less liquid permeable than the liquid permeable wall portion.
Regarding Claim 19, in Morgan the liquid permeable wall portion is configured to be folded into the remainder portion (see Fig. 1; Col. 2, Ln. 1-9 since the bag is formed of a flexible cloth or mesh material it may be folded and bunched as desired and inverted into the portion 40 of the trap).
Regarding Claim 20, Morgan discloses a cover (26) configured to be secured to the tissue trap body (see Fig. 1).
Regarding Claim 21, Examiner again notes that the collection sac is not positively required, whereby the bag of Morgan could be used with any suitably dimensioned collection sac inclusive to a “thin wall collection sac”.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,285,814 (“Morgan”).
Regarding Claim 2, Morgan discloses the invention substantially as claimed except that that the volume of the tissue trap is “configured to collect at least 20 grams, at least 30 grams or at least 40 grams of tissue debris”. In the instant case Examiner notes that “grams” is not a unit of volume, but of mass, and therefore the ability of the container to collect any particular mass of tissue is dependent not only upon the volume of the trap, but also the density of the tissue collected whereby 20 grams of a low density tissue (e.g. adipose tissue) will have a substantially higher volume than 20 grams of a dense body tissue (e.g. a bone). Morgan fails to disclose the volume of the trap, however it would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system to be sufficiently large to collect to collect a sufficiently large volume of material, inclusive to 20 grams (or more), since it has been held that such a mere change in the size of an invention is an obvious design choice which cannot sustain patentability when it affects only a predicted and expected outcome, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/30/2026
