Final Rejection
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 .
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 30 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 30 recites the limitations “submersion retention element actively prevents the tissue sample form surfacing” in line 11. It is unclear as to how submersion retention element actively prevents the tissue sample form surfacing since the top wall of the basket is stationarily immovable. Appropriate clarification is required.
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 30,32,38,46-53,58 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Bils (US 4,202,289) in view of Dinh (US 4,656,929).
Referring to claims 30,32 and 48. Bils discloses a method of staining a sample (see abstract line 4), the method comprising:
providing a freshly resected tissue sample (specimen; Figure 5);
providing a receptacle (Figure 1), the receptacle (Figure 1) comprising a container (V; Figure 1) no more than 60% filled with staining agent solution (no more than 60% filed but can be less than 60% liquid solution; Figure 1 and 9) and a removable basket (C) comprising a sample submersion retention element (22);
placing the tissue sample (specimen; Figure 5) in the basket (C) by removably inserting the sample (sample can be removed) through a vertically oriented opening in a side of the basket (opening of the basket positioned on the top side of the basket but not specifically in the side wall but not vertically oriented)
positioning the basket (C) in the container (V) to submerge the tissue sample (specimen submerged as in Figure 1);
submerging the tissue sample in the staining agent solution (as shown in Figure 1) in the container (V) for a period of time (time specimen is submerged), thereby staining the tissue sample (see abstract line 4),
wherein the sample submersion retention element (22) is disposed to prevent (member 22 is disposed at the bottom of the basket which prevents the specimen from falling into the container and surface in the staining agent solution) the tissue sample (specimen) from surfacing in the staining agent solution during the submerging (see Figure 1); and
removing the tissue sample from the container (removing the specimen from container V),
wherein the method is performed intraoperatively (can be performed at any suitable location or time).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Bils to include the method as recited to be performed intraoperatively because the method can be performed in the course of surgery thus providing rapid information about the specimen.
Bils does not disclose placing the tissue sample in the basket by removably inserting the sample through a vertically oriented opening in a side of the basket and
does not disclose the container comprising a retention element disposed above the sample such that the sample submersion retention element prevents the tissue sample from surfacing.
Dinh discloses a liquid immersion apparatus (Figure 2) wherein a container comprises a retention element (58; Figure 2) is disposed above the sample (article inserted in basket) such that the sample submersion retention element (58; Figure 2) actively prevents the tissue sample from surfacing (see Figure 2) and
further wherein the sample (article inserted in basket) is placed in the basket (62) through a vertically oriented opening (64) in a side of the basket (see vertical opening in the front side wall of container 62 as shown in Figure 2).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Bils to include a container comprising a retention element disposed above the sample such that the sample submersion retention element actively prevents the tissue sample from surfacing and wherein the sample is place in the basket through a vertically oriented opening in a side of the basket as taught by Dinh because a container comprising a retention element disposed above the sample and wherein placing the sample in place in the basket through a vertically oriented opening in a side of the basket would assure that the sample stays submerged within the liquid and at the same time is easy to load through the front opening.
Referring to claim 59. Dinh discloses a liquid immersion apparatus (Figure 2) wherein the vertically oriented opening (64; Figure 2) remains open (see open front face 64; Figure 2) during staining (submersion) of the sample (as shown in Figure 2).
Referring to claims 38,49,50,51 and 58. Bills in view of Dinh disclose a method of staining a sample (see abstract line 4), wherein the tissue sample (specimen) has a volume of at least 2 mL and no more than 300 mL.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have comprised the tissue sample having a volume in the range of 2mL to 300 mL, since it has been held that where the general conditions of a 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 233.
Referring to claim 46. Bills in view of Dinh disclose a method of staining a sample (see abstract line 4), the sample is submerged in the solution for a predetermined time.
Bills in view of Dinh do not disclose wherein the period of time during which the tissue sample is submerged is at least 10 seconds and no more than 1 minute.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have comprised the period of time during which the tissue sample is submerged is at least 10 seconds and no more than 1 minute, since it has been held that where the general conditions of a 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 233.
Referring to claim 47. Bills in view of Dinh disclose a method of staining a sample (see abstract line 4), the sample surface is stained in the solution.
Bills in view of Dinh do not disclose wherein the submerging stains a surface layer of the tissue sample to a penetration depth in a range of 0.05 mm to 1 mm.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have comprised the submerging stains a surface layer of the tissue sample to a penetration depth in a range of 0.05 mm to 1 mm, since it has been held that where the general conditions of a 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 233.
Referring to claim 52 and 53. Bills in view of Dinh disclose a method of staining a sample (see abstract line 4), wherein the sample is a very small and thin tissue to be examined (Col. 1 line 8).
Bills in view of Dinh do not disclose wherein the tissue sample is a freshly resected breast tissue sample.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have comprised the tissue sample as being a freshly resected breast tissue sample because it would allow a greater diversity of tissue types to be stained effectively for examination.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Bils (US 4,202,289) in view of Dinh (US 4,656,929) and further in view of Tateya (EP 0881481 A1).
Referring to claim 36. Bills in view of Dinh do not disclose a method for providing a second receptacle comprising a second container for rinsing a sample.
Tateya discloses a method providing a second receptacle comprising a second container no more than 60% filled with rinsing solution (no more than 60% filed but can be less than 60% liquid solution; see Figures 4A and 4B; Col. 2 lines 33-52);
removing the basket (8) from the receptacle (Figure 1B);
positioning the basket (8) in the second container thereby submerging the tissue sample in the rinsing solution (Figure 4A); and
removing the basket (8) from the second container (Figure 4B) after a period of time of no more than 30 seconds.
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Bills in view of Dinh to include a second receptacle comprising a second container for rinsing a sample as taught by Tateya because the sample can be washed prior to a user handling the specimen for analysis.
Claim 54 are rejected under 35 U.S.C. 103 as being unpatentable over Bils (US 4,202,289) in view of Dinh (US 4,656,929) and further in view of Haywood (WO 03/031065 A1).
Referring to claim 54. Bils in view of Dinh do not specifically disclose wherein the tissue sample is less dense than the staining agent solution such that, during the submerging, the sample submersion retention element prevents the sample from surfacing.
Haywood discloses a basket apparatus for biological samples (10; Figure 10) wherein the tissue sample (136; Figure 10) is less dense than the staining agent solution such that, during the submerging (see Figure 5 and 10), the sample submersion retention element (82 Figure 5) prevents the sample from surfacing (prevents the sample of floating upwards (see Figure 10).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Bils in view of Dinh to include the tissue sample is less dense than the staining agent solution such that, during the submerging, the sample submersion retention element prevents the sample from surfacing as taught by Haywood because it can be assured the sample is completely submerged in the staining agent solution.
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive. See new rejections cited in light of Bils (US 4,202,289) in view of Dinh (US 4,656,929). Dinh discloses a submersible basket with an vertical opening in the front face of the basket as claimed.
Applicant argues the limitations of claim 30 “the sample submersion retention element is disposed to prevent the tissue sample from surfacing in the staining agent solution during the submerging,” are not disclosed by the cited reference. In view of the Examiner, the primary reference of Bils (US 4,202,289) discloses the sample submersion retention element (22) is disposed to prevent the tissue sample from surfacing in the staining agent solution during the submerging wherein the Bils reference discloses a member 22 is disposed at the bottom of the basket which prevents the specimen from falling into the container and resurfacing in the staining agent solution. It is suggested the Applicant positively define the position of the retention element on the basket.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAKESH KUMAR whose telephone number is (571)272-8314. The examiner can normally be reached M-TH from 8AM-6:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gene Crawford can be reached at (571) 272-6911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RAKESH KUMAR/ Primary Examiner, Art Unit 3651
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