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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 7-9, 11-12, 14, 16-19, 21-24, 34-40rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 1, 16, there is no support in the original disclosure for an uppermost planar surface area defined by a contiguous outer periphery and thus it constitutes new matter. In particular, the original disclosure is silent regarding the structure of the indicia having a planar surface area and a contiguous outer periphery. Regarding claim 38-39, there is no support in the original disclosure for the uppermost planar surfaces being coplanar and thus it constitutes new matter. In particular, the original disclosure is silent regarding uppermost planar surfaces and surfaces being coplanar and parallel to base surface.
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 2, 17, 27, 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 claim 2, 17, 27, the scope of the claims is unclear because of the recitation of a geometric shape or character which encompasses an infinite number of possibilities that renders the scope of the claims unclear.
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.
Claim(s) 1-2, 7-9, 11, 14, 34, 40 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2014/0083886 to Winterrowd et al. (Winterrowd).
Regarding claim 1, Winterrowd discloses an instrument tray indicator panel (Fig 2a) comprising a three-dimensional indicia (212/402c) that can be selectively attached to an instrument tray in a position where the three-dimensional indicia outwardly projects from an external surface of the tray opposite an interior of the tray configured to carry medical components therein since it has the structure as recited, the three-dimensional indicia comprising a unique structure configured to identify the medical components when carried within the instrument tray since it has the structure as recited, wherein the unique structure of the three-dimensional indicia includes an uppermost planar surface area (A, Fig 3a below or A, Fig 4 below) defined by a contiguous outer periphery (B, Fig 3a below or B, Fig 4 below) together providing external tactile feedback sufficient to identify the unique structure of the three-dimensional indicia since it has the structure as recited. In particular, the panel of Winterrowd is capable of functioning with a tray as recited and the thee-dimensional indicia (234/402c) are unique in that they are different from other three-dimensional indicia (252) and are capable of holding unique medical components.
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Regarding claim 2, Winterrowd further discloses three-dimensional indicia (254) comprising a geometric shape (Fig 3a).
Regarding claim 7, Winterrowd further discloses multiple of the three-dimensional indicia (254, 252) are carried by a baseplate (256) that can be selectively attached to an instrument tray since it has the structure as recited.
Regarding claim 8, Winterrowd further discloses each of the multiple three-dimensional indicia (254, 252) can be arranged to generally align with a different row of medical components within the interior of the tray since it has the structure as recited.
Regarding claim 9, Winterrowd further discloses each of the multiple three-dimensional indicia (254, 252) comprise different structure that can symbolize different medical components since it has the structure as recited.
Regarding claim 11, Winterrowd further discloses unique structure of three-dimensional indicia comprising a circle (402c, Fig 4).
Regarding claim 14, Winterrowd further discloses the contiguous outer periphery three-dimensional indicia including an edge break comprising a chamfer, fillet, radius or bevel (B, Fig 3a above).
Regarding claim 34, Winterrowd further discloses baseplate (256) includes at least one mounting aperture (260).
Regarding claim 40, Winterrowd further discloses multiple indicia (252a, 252b) upwardly extend from top surface of the base plate (256) and each comprise a thickness greater than a thickness of the baseplate (Fig 3a).
Claim(s) 1, 16, 25, 41 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2006/0213794 to Foreman et al. (Foreman).
Regarding claim 1, Foreman discloses an instrument tray indicator panel (Fig 3) comprising a three-dimensional indicia (44) that can be selectively attached to an instrument tray (30) in a position where the three-dimensional indicia outwardly projects from an external surface of the tray opposite an interior configured to carry medical components therein (Fig 5) since it has the structure as recited, the three-dimensional indicia (44) comprising a unique structure configured to identify the medical components when carried within the instrument tray since it has the structure as recited, wherein the unique structure of three-dimensional indicia includes an uppermost planar surface area (A, Fig 3 below) defined by a contiguous outer periphery (B, Fig 3 below) together providing external tactile feedback sufficient to identify the unique structure of the three-dimensional indicia since it has the structure as recited. In particular, the secondary case of Foreman can function as a three-dimensional indicia and the three-dimensional indicia (44) is unique in that it is different from other three-dimensional indicia (46) and are capable of holding unique medical components.
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Regarding claim 16, Foreman discloses an instrument tray indicator system (Fig 5) comprising an instrument tray (30), a three-dimensional indicia (44) selectively coupled to the instrument tray in a position outwardly projecting from an external surface of the tray opposite an interior configured to carry medical components therein, the three-dimensional indicia comprising a unique structure identifying the medical components when carried within the instrument tray since it has the structure as recited and wherein the unique structure of the three-dimensional indicia includes an uppermost planar surface area (A, Fig 3 above) defined by a contiguous outer periphery (B, Fig 3 above) providing external tactile feedback to identify the unique structure of the three-dimensional indicia since it has the structure as recited. In particular, the secondary case of Foreman can function as a three-dimensional indicia and the three-dimensional indicia (44) is unique in that it is different from other three-dimensional indicia (46) and are capable of holding unique medical components.
Regarding claim 25, Foreman discloses an instrument tray indicator system (Fig 5) comprising a sterile instrument tray (30), multiple three-dimensional indicia (44, 46) selectively attachable to the instrument tray, each having a different unique structure (Figs 4-5), wherein the unique structure of each of the three-dimensional indicia comprises a size and shape outwardly projecting from an external surface of the sterile instrument tray and being defined by an uppermost surface area (A, Fig 3 above) enclosed by a periphery thereof (B, Fig 3 above) providing external tactile feedback of each unique structure of the respective three-dimensional indicia to identify medical components (intended use) since it has the structure as recited and wherein each of the three-dimensional indicia include an edge break comprising a chamfer, fillet, radius or bevel. In particular, the each of the indicia has curved radius as shown in Figs 3-4. In particular, the secondary cases of Foreman can function as a three-dimensional indicia and the three-dimensional indicia (44) is unique in that it is different from other three-dimensional indicia (46) and are capable of holding unique medical components.
Regarding claim 41, Foreman further discloses each unique structure of the indicia (44, 46) corresponds to a different row (24) within an interior of the sterile instrument tray (30) (Fig 1) since it has the structure as recited.
Claim(s) 1, 7, 35-39 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2012/0012488 to Schweinberg et al. (Schweinberg).
Regarding claim 1, Schweinberg discloses an instrument tray indicator panel (176) comprising a three-dimensional indicia (36) that can be selectively attached to an instrument tray in a position where the three-dimensional indicia outwardly projects from an external surface of the tray opposite an interior of the tray configured to carry medical components therein since it has the structure as recited, the three-dimensional indicia comprising a unique structure configured to identify the medical components when carried within the instrument tray since it has the structure as recited, wherein the unique structure of the three-dimensional indicia includes an uppermost planar surface area (A, Fig 30 below) defined by a contiguous outer periphery (B, Fig 30 below) together providing external tactile feedback sufficient to identify the unique structure of the three-dimensional indicia since it has the structure as recited. In particular, the panel of Schweinberg is capable of functioning with a tray as recited and the thee-dimensional indicia (36) are unique in that they are different from other three-dimensional indicia (36) and are capable of holding unique medical components.
Regarding claim 7, Schweinberg further discloses multiple of the indicia (36) are carried by a baseplate (32) selectively attachable to an instrument tray since it has the structure as recited.
Regarding claim 35, Schweinberg further discloses unique structure of the indicia (36) extends upwardly from a base surface (176) of the instrument tray indicator panel.
Regarding claim 36, Schweinberg further discloses a second three-dimensional indicia (36) having a second unique structure comprising a second uppermost planar surface area defined by a second contiguous outer periphery upwardly extending from base surface (24) of indicator panel (Fig 30).
Regarding claim 37, Schweinberg further discloses uppermost planar surface area defined by contiguous outer periphery has a different shape than second uppermost planar surface area defined by second contiguous outer periphery (Fig 1, letters A, B, C have different shape).
Regarding claim 38, Schweinberg further discloses uppermost planar surface areas (A, Fig 30 below) of the indicia are coplanar (Fig 30).
Regarding claim 39, Schweinberg further discloses uppermost planar surface areas (A, Fig 30 below) are parallel to base surface (176) (Fig 30)
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Winterrowd.
Regarding claim 12, Winterrowd discloses the panel of claim 1 except for the thickness dimensions as recited. However, one of ordinary skill in the art would have found it obvious to change the dimensions of the bracket thickness to that as recited in order to have a strong and lightweight instrument support since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 16-19, 21-27, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0077222 to Heid et al. (Heid) in view of US 2012/0012488 to Schweinberg et al. (Schweinberg).
Regarding claim 16, Heid discloses an instrument tray indicator system comprising an instrument tray (1a) and a label (18) located exterior of the tray. Heid does not teach the label having three-dimensional indicia. However, Schweinberg discloses a container label (32) having unique three-dimensional indicia (36) protruding from the label, wherein the unique structure of the indicia includes an uppermost planar surface area (A, Fig 30 below) defined by a contiguous outer periphery (B, Fig 30 below) providing externing tactile feedback of the unique structure of the indicia since it has the structure as recited. One of ordinary skill in the art would have found it obvious to substitute the indicia of the Heid label with three-dimensional indicia as suggested by Schweinberg in order to provide identification. Furthermore, the modification would have resulted in the three-dimensional indicia being selectively coupled to the tray in a position outwardly projecting from external surface opposite interior, the indicia having a unique structure that can identify medical components, thickness of the indicia sufficient to identify the unique structure of the indicia to provide external tactile feedback (€0053, Schweinberg).
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Regarding claim 17, the modified Heid further teaches unique structure of three-dimensional indicia (36, Fig 1) comprising letter.
Regarding claim 18, the modified Heid discloses the system of claim 16 except for the thickness dimensions as recited. However, one of ordinary skill in the art would have found it obvious to change the dimensions of the indicia thickness to that as recited in order to have the indicia more visible since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 19, the modified Heid further discloses instrument tray (1a) includes a recessed panel (8) having the three-dimensional indicia (36, Schweinberg) coupled thereto in parallel relation, the recessed panel (32, Schweinberg) extending inwardly by a depth greater than a thickness of the indicia (Fig 30, Schweinberg).
Regarding claim 21, the modified Heid further discloses multiple three-dimensional indicia (36, Schweinberg) can be arranged to generally align with a different row of medical components within the interior of the tray since it has the structure as recited.
Regarding claim 22, the modified Heid further discloses each of the multiple three-dimensional indicia (36, Schweinberg) comprise different structure that can symbolize different medical components since it has the structure as recited.
Regarding claim 23, the modified Heid further discloses three-dimensional indicia comprises a cutout (12a, Schweinberg) formed within a sidewall of the instrument tray.
Regarding claim 24, the modified Heid further teaches indicia including an edge break comprising chamfer, fillet, radius or bevel since they are characters.
Regarding claim 25, Heid discloses an instrument tray indicator system comprising a sterile instrument tray (1a) and a label (18) located on exterior surface of the tray opposite an interior capable of carrying multiple medical components. Heid does not teach the label having three-dimensional indicia. However, Schweinberg discloses a container label (32) having multiple different unique three-dimensional indicia (36) protruding from the label (Fig 30), wherein the unique structure of each of the three-dimensional indicia comprise a size and shape outwardly projecting from an external surface of the tray (Fig 30) and being defined by an uppermost surface area (A, Fig 30 above) enclosed by a periphery (B, Fig 30 above) thereof providing external tactile feedback of each unique structure of the indicia since it has the structure as recited. One of ordinary skill in the art would have found it obvious to substitute the indicia of the Heid label with three-dimensional indicia as suggested by Schweinberg in order to provide identification. Furthermore, the modification would have resulted in the three-dimensional indicia being selectively coupled to the tray in a position outwardly projecting from external surface opposite interior of the tray, the indicia having a unique structure that can identify medical components, size and shape of each indicia to provide external tactile feedback sufficient to identify the unique structure of the indicia (€0053, Schweinberg), each indicia including an edge break comprising a chamfer, fillet, radius or bevel since they are characters.
Regarding claim 26, Heid further discloses external surface of the tray comprising a front panel (Fig 1).
Regarding claim 27, the modified Heid further discloses each indicia (36, Schweinberg) comprising a different letter and selectively removably attachable to the tray in modular relation relative thereto since it has the structure as recited.
Regarding claim 29, the modified Heid discloses the system of claim 25 except for the thickness dimensions as recited. However, one of ordinary skill in the art would have found it obvious to change the dimensions of the indicia thickness to that as recited in order to have the indicia more visible since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 3/3/2026 have been fully considered but they are not persuasive. Applicant argues that support for the recitation of uppermost planar surface area defined by contiguous outer periphery is shown in Figs 3-4, 6 but the drawings do not show the surfaces being planar. Applicant argues that Fig 5 shows multiple indicia with coplanar uppermost planar surfaces; however, there is no suggestion that the surfaces are planar, let along coplanar, since the drawings are not to scale. Applicant further argues the indicia comprising a number, letter, shape or character is clear to one of ordinary skill in the art. This is not persuasive because there are infinite possibilities of what a “character” can be and thus it fails to define the metes and bounds of the claim. Applicant has failed to define what exactly a “character” is defined as.
Applicant further argues that Winterrowd discloses pins that are fasteners and that the structure of the pin is not unique because there are other pins exactly alike. This is not persuasive because Winterrowd specifically discloses the fasteners as (402a, 402b, 402c) which differentiate their structures and they are unique because they are different from other structures on the panel such as (212). It is noted that insofar as applicant has defined their structure (60”, 60”’) to be unique even though they are exactly alike, then so too does Winterrowd discloses the fasteners (402a, b, c) to be unique even if they have like structure. Applicant further argues that the support member 254 does not have a planar surface since outer periphery falls off at its end. However, the outer periphery of applicant’s structure (60, 60’, 60”) in Fig 5 also falls off at its end to connect to plate (20). Thus, insofar as applicant’s structure as a planar surface, so too does the structure of Winterrrowd.
In response to applicant's argument that the bracket of Winterrowd is intended to be placed within a tray and to only provide a visible indication of specific instrumentation and not a tactile one, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant further argues the rejection of claim 7 stating that the bracket (212) was the indicia and thus (254, 252) cannot be other indicia since they are part of the bracket. However, the rejection clearly listed (402c) as an alternative indicia which would be different from other indicia (254, 252) since they are separate parts.
Applicant further argues the rejection of claim 40 stating that Winterrowd is silent regarding the thickness of the support members with respect to attachment member. However, according to applicant, drawings are part of the disclosure and Fig 3a of Winterrowd show the thickness (in the vertical direction) of support members (252a, 252b) far greater than thickness (in the vertical direction) of attachment member (256).
In response to applicant's argument that Foreman does not teach structural component that is a unique structure that identifies medical components carried within the instrument tray because they are used for different purposes, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the components (44, 46) are different and thus unique and are capable of providing external tactile feedback since they have the structure as recited.
Applicant further argues that Foreman does not teach unique structure of indicia corresponding to different row within an interior of the instrument tray because Foreman does not teach rows. This is not persuasive because as shown in Fig 5, wires (24) are in rows and each can correspond to a different indicia since it has the structure as recited.
In response to applicant's argument that Schweinberg discloses a utility box that houses utility equipment and is not used to identify medical components when carried within the tray, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In particular, since Schweiberg discloses the structure of a tray as recited, then it can be used to identify medical components as recited even if Schweinberg teaches the tray to perform a different function from what applicant has claimed.
In response to applicant's argument that Heid and Schweinberg 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 container trays with label and external indicators.
In response to applicant's argument that Schweinberg is silent with respect to indicia specifically designed for tactile feedback of medical instrument, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that Schewinberg is silent regarding thickness of the indicia. However, applicant admits that drawings are part of the disclosure and Fig 30 of Schweinberg discloses recessed panel extending inwardly by a depth greater than thickness of indicia (36).
Applicant further argues that Heid/Schweinberg does not disclose multiple three dimensional indicia arranged to generally align with different row of medical components within interior of the instrument tray because Heid does not disclose the container having different rows of medical components. This is not persuasive because so long as prior art has the structure of the multiple three-dimensional indicia as recited, then it can be used to align with different row of medical components within the tray since applicant does not explicitly claim the different row of medical components within the tray.
Conclusion
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571)272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT POON/Examiner, Art Unit 3735
Prosecution Insights