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 .
Applicant’s election without traverse of Group I, claims 1-19 in the reply filed on 08/05/2025 is acknowledged, and further elected Group A, Figs. 3-6 and claims 1-13 as per the telephone communication on 08/26/2025 between Chrystal A. Tomblyn and Examiner Bui.
Claims 14-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
Figures 1 and 2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated (see paragraphs [0008]-[0009]). See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-13 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.
In claim 1, the phrase “the sterile field fluid system comprises a basin having sidewalls defining a cavity” defines the cover in reference a sterile fluid system which is undefined and has not been positively claimed rendering the claims vague and indefinite because it is not clear what structural limitations applicant intends to encompass with such language. The phrases “the same as a shape of the cavity” in claim 3, “allows access to the cavity” in claim 5, “the center of the cavity” in claim 9, and “provide access to the cavity” in claim 10 are vague, confusing and indefinite because “a cavity” is belong to “a basin” which is not positively recited in the claims. Not clear whether a cavity is belong to a basin or the bottom layer?
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 11 and 13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Krueger et al. (5,868,253; hereinafter Krueger). To the extent that the Examiner can determine the scope of the claims, Krueger discloses an inner tray/cover (20, 24) comprising a bottom layer (20) which is inherently capable to be positionable on an outer surface of a sterile field fluid system, wherein the sterile field fluid system comprises a basin having sidewalls defining a cavity, and a top layer (24) adjacent to the bottom layer and the top layer having a surface area smaller than a surface area of the bottom layer. Krueger further discloses at least a portion of the top layer is connected to the bottom layer (Fig. 4 & column 3, lines 63-65) and the bottom layer is configured to conform to the basin and the top layer is sized to cover the cavity of the basin.
As to claim 2, Krueger further discloses the top layer is connected to the bottom layer by an adhesive, bond, thermal weld, or ultrasonic weld, interlocking mechanism, or combinations thereof (column 3, lines 63-65 & column 4, lines 46-64).
As to claim 3, Krueger discloses a shape of the top layer is substantially the same as a shape of the cavity.
As to claim 4, see Fig. 4.
As to claim 11, Krueger discloses the top layer comprises a material (column 4, lines 45-64) which is inherently capable for reuse or re-sterilization.
As to claim 13, it appears that Krueger discloses the top layer, the bottom layer, or both comprise a pre-sterilized material for holding a medical device.
Claim(s) 1-4, 11 and 13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cohen et al. (4,750,619; hereinafter Cohen). To the extent that the Examiner can determine the scope of the claims, Cohen discloses an inner receptacle/cover (14, 24) comprising a bottom layer (14) which is inherently capable to be positionable on an outer surface of a sterile field fluid system, wherein the sterile field fluid system comprises a basin having sidewalls defining a cavity, and a top layer (24) adjacent to the bottom layer and the top layer having a surface area smaller than a surface area of the bottom layer. Cohen further discloses at least a portion of the top layer is connected to the bottom layer (Fig. 2 & column 2, lines 53-62) and the bottom layer is configured to conform to the basin and the top layer is sized to cover the cavity of the basin.
As to claim 2, Cohen further discloses the top layer is connected to the bottom layer by an adhesive, bond, thermal weld, or ultrasonic weld, interlocking mechanism, or combinations thereof (column 2, lines 53-62).
As to claim 3, Cohen discloses a shape of the top layer is substantially the same as a shape of the cavity.
As to claim 4, see Fig. 2.
As to claim 11, Cohen discloses the top layer comprises a material (column 2, lines 53-54) which is inherently capable for reuse or re-sterilization.
As to claim 13, it appears that Cohen discloses the top layer, the bottom layer, or both comprise a pre-sterilized material for holding a medical device.
Claim(s) 1-4, 11 and 13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Knowlton et al. (2011/0036736; hereinafter Knowlton). To the extent that the Examiner can determine the scope of the claims, Knowlton discloses a medical device/cover (10, 36) comprising a bottom layer (10) which is inherently capable to be positionable on an outer surface of a sterile field fluid system, wherein the sterile field fluid system comprises a basin having sidewalls defining a cavity, and a top layer (36) adjacent to the bottom layer and the top layer having a surface area smaller than a surface area of the bottom layer. Knowlton further discloses at least a portion of the top layer is connected to the bottom layer (Fig. 6 & [0043]) and the bottom layer is configured to conform to the basin and the top layer is sized to cover the cavity of the basin.
As to claim 2, Knowlton further discloses the top layer is connected to the bottom layer by an adhesive, bond, thermal weld, or ultrasonic weld, interlocking mechanism, or combinations thereof [0043].
As to claim 3, Knowlton discloses a shape of the top layer is substantially the same as a shape of the cavity.
As to claim 4, see Fig. 6.
As to claim 11, Knowlton discloses the top layer comprises a material [0042] which is inherently capable for reuse or re-sterilization.
As to claim 13, it appears that Knowlton discloses the top layer, the bottom layer, or both comprise a pre-sterilized material for holding a medical device.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 5-10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krueger or Cohen or Knowlton in view of The Official Notice and/or Sullivan et al. (11,077,996; hereinafter Sullivan).
As to claim 5, each of Krueger or Cohen or Knowlton discloses the cover as above having most of the limitations of the claim except for a surface of the top layer comprises at least one opening that allows access to the cavity as claimed. The Official Notice is taken of an old and conventional practice of providing a cover comprising a bottom layer and a top layer, and a surface of the top layer defines at least one opening that allows access to a cavity in the bottom layer. Sullivan, is cited by way of example only, teaches a cover (100) comprising a bottom layer (300; Figs. 1 & 4), a top layer (200) adjacent to the bottom layer, and a surface of the top layer defines at least one opening (314; Fig. 2) that allows access to a cavity in the bottom layer. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention in view of The Official Notice and/or Sullivan to modify the cover of Krueger or Cohen or Knowlton so the cover is constructed with a surface of the top layer comprises at least one opening that allows access to the cavity as claimed to provide more convenience for a user to access to the contents.
As to claim 6, Sullivan further teaches that the at least one opening comprises a slit (column 7, lines 48-58).
As to claim 7, Sullivan teaches the top layer comprises a flap (218; Fig. 2) as claimed.
As to claim 8, Sullivan teaches the flap comprises a repositionable adhesive or mechanical closure (240; column 8, lines 1-5).
As to claim 9, see Fig. 2 of Sullivan.
As to claim 10, see Fig. 2 or Fig. 3 of Sullivan.
As to claim 12, see Fig. 5B of Sullivan.
As to claim 13, it appears that each of Krueger or Cohen or Knowlton discloses the top layer, the bottom layer, or both comprise a pre-sterilized material for holding a medical device. To the extent that if Krueger or Cohen or Knowlton fails to disclose the top layer, the bottom layer, or both comprise a pre-sterilized material, The Official Notice is taken of an old and conventional practice of providing a cover comprising a top layer and a bottom layer, and the top layer, the bottom layer, or both comprise a pre-sterilized material for better protecting the contents. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention in view of The Official Notice to modify the cover of Krueger or Cohen or Knowlton so the cover is constructed with the top layer, the bottom layer, or both comprise a pre-sterilized material for better protecting the contents.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUAN K BUI whose telephone number is (571)272-4552. The examiner can normally be reached Generally M-F, 7-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Avilés can be reached on 571-270-5531 or orlando.aviles-bosques@uspto.gov. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUAN K BUI/
Primary Examiner, Art Unit 3736