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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
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) 1, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0036736 to Knowlton et al. (Knowlton) in view of US Patent No. 6,450,333 to McClenahan et al. (McClenahan).
Regarding claim 1, Knowlton discloses a container (Fig 8) for storing a biological tissue comprising an inner container (10) used to store biological tissue and an outer container (40) which seals and accommodates the inner container (10), the inner container (10) being separable from outer container (40) (Fig 8) wherein the outer container (40) comprises a gas permeation part which allows a sterilization gas to flow into the inner container which is housed in the outer container from outside the outer container, or the outer container (40) and the inner container (10) are made of a material (polymers, €0051) which allows a permeation of radioactive ray or an electron beam, the inner container (10) comprises a container having an upper opening (24) and a bottom (22) and capable of accommodating the biological tissue and a solution that hydrates and moisturizes the tissue in solid state since it has the structure as recited, a lid part (36) capable of closing the opening of the container, the lid part (36) being detachable from the container so as to be in an opening state of the opening of the container (Fig 8), the outer container and inner container are pierceable by an injection needle which injects the solution from outside the outer container since the lids (36, 60) are flat and flexible and depending on the strength of the injection needle, the inner container comprises a unit (26, 22) which can retain the biological tissue in the container with an original form of the tissue being maintained since it has the structure as recited. Knowlton does not teach unit comprising a pair of gripping parts as recited. However, McClenahan teaches a unit (Fig 7) comprising a container (48) and lid part (46) which closes an opening, a pair of gripping parts (62, Fig 9) wherein one part of the pair of gripping parts comprises a first protruding part (62 on container 48) protruded upwardly in the bottom of the inner container which forms a first portion for gripping and retaining tissue (intended use), the other part of the pair of gripping parts comprises a second protruding part (62 on lid part) protruded downwardly in the lid part (46) which forms a second portion for gripping and retaining tissue (intended use), and wherein the container is configured such that when the opening of the inner container is closed with the lid part, the pair of gripping parts grips and retains the tissue from above and below since it has the structure as recited (col. 5, ll. 30-35), wherein the first protruding part is aligned with the second protruding part (Fig 7), wherein the first protruding part has a recessed part (64) provided therein an area where the first protruding part and second protruding part face each other. One of ordinary skill in the art would have found it obvious to incorporate gripping parts to the bottom of the inner container and lid part of the modified Knowlton as suggested by McClenahan in order to facilitate holding of the medical instrument.
Regarding claim 6, Knowlton further discloses the recessed part (64) configured to have a cross-section shape of a tissue as recited so that the gripping parts can retain the tissue in the recessed part. In particular, since prior art discloses the structure of the container as recited, then it would be capable of functioning with a tissue as recited.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of McClenahan and US 2005/0150855 to Woods.
Regarding claim 2, Knowlton teaches the container of claim 1 but does not teach injection port on inner container and mark on outer container aligned with the port. However, Woods discloses a container (10) comprising an outer (12) and inner (14) container with injection port (18) aligned with mark (16) on outer container (12) to allow for penetration of needle to retrieve any liquid. One of ordinary skill in the art would have found it obvious to incorporate injection port and mark to Knowlton as suggested by Woods in order to allow for penetration of a needle for any liquid retrieval.
Regarding claim 3, Knowlton further discloses a plug (at 16) pierceable by injection needle at position of outer container aligned with injection port.
Regarding claim 4, Knowlton further discloses inner container comprising a unit (Fig 9) that can retain the tissue but does not teach an injection port on the container or lid part. However, Woods discloses a container (10) comprising an inner container (14) with injection port (18) for penetration of a needle to retrieve liquid. One of ordinary skill in the art would have found it obvious to incorporate injection port to Knowlton as suggested by Woods in order to allow for penetration of a needle for any liquid retrieval.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of McClenahan and US Patent No. 8,006,839 to Hafner.
Regarding claim 7, the modified Knowlton teaches the container of claim 1 and further teaches inner container formed from flexible material (€0034) but does not teach lid part comprising a projection. However, Hafner discloses an inner container (14) formed from flexible material, lid part (16) comprises a projection part (78) configured to fit into opening of the container (14) when the lid part closes the opening, so that when side walls of the container are pressed and bent, the projection part slips upward on an inner surface of the container and detaches from the container since the walls are deformable (col. 4, ll. 60-65). One of ordinary skill in the art would have found it obvious to substitute the lid of Knowlton with a functionally equivalent lid having projections such that pressing the container side walls detaches lid from the container as suggested by Hafner in order to facilitate sealing and opening of the inner container.
Response to Arguments
Applicant's arguments filed 2/3/2026 have been fully considered but they are not persuasive. Initially, it is noted that applicant does not argue the rejection of the dependent claims.
In response to applicant's argument that Knowlton and McClenahan is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both are directed to tray containers for holding and storing objects.
Applicant argues that McClenahan does not teach the gripping parts comprising protruding parts that grip and retain a tissue. However, McClenahan is now interpreted such that the protruding part is now the entirety of reinforcing rib (62) since reinforcing ribs (62) protrudes upwardly in the bottom of the container and protrudes downwardly in the lid part. In particular, the ribs (62) have recesses (64) capable of gripping and retaining a biological tissue depending on the size and dimensions of such tissue.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT POON whose telephone number is (571)270-7425. The examiner can normally be reached Monday thru Friday, 8:30 am to 6:00 pm.
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/ROBERT POON/Examiner, Art Unit 3735