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 Status
This office action is in response to the filing of 07/25/2024. Claims 1-20 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) was filed on 01/29/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 2, 6, 7, 9, 13 and 18-20 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 claim 2 which recites “wherein the inner part and the outer part are each formed by a single sheet of cardboard”, which renders the claim indefinite because the specification has outer part 12 as an outer box, Fig. 1, and inner part 14 as an insert to go into part 12, Fig. 4, as such, the examiner is unable to determine exactly what the applicant is claiming.
While the Examiner might speculate as to what is meant by the claim language, the uncertainty provides the Examiner with no proper basis for making the comparison between that which is claimed and the prior art. Rejections under 35 U.S.C. § 103 should not be based upon considerable speculation as to the meaning of terms employed and assumptions as to the scope of the claims. In re Steele, 134 USPQ 292. When no reasonably definite meaning can be ascribed to certain terms in a claim, the subject matter does not become obvious, but rather the claim becomes indefinite. In re Wilson, 165 USPQ 494.
Regarding claims 6 and 13 which recites “the inner part includes an upper rack surface and a lower rack surface”, which renders the claim indefinite because claim 1 already recites a rack surface and the examiner is unable to determine if that surface includes the upper and lower rack surfaces of claim 6.
In order to advance prosecution of the application, the office will interpret the limitation as the rack surface further comprising a lower and upper rack surface.
Regarding claim 7 which recites “a medical device” which renders the claim indefinite because the examiner is unable to determine if this device is different for the medical device of claim 1.
In order to advance prosecution of the application, the office will interpret the limitation as the same device as claim 1.
Regarding claim 9 which recites “wherein the first single sheet of cardboard and the second single sheet of cardboard are each part of a same single sheet of cardboard”, which renders the claim indefinite because the specification has outer part 12 (second single sheet) as an outer box, Fig. 1, and inner part 14 (first single sheet) as an insert to go into part 12, Fig. 4, as such, the examiner is unable to determine exactly what the applicant is claiming.
While the Examiner might speculate as to what is meant by the claim language, the uncertainty provides the Examiner with no proper basis for making the comparison between that which is claimed and the prior art. Rejections under 35 U.S.C. § 103 should not be based upon considerable speculation as to the meaning of terms employed and assumptions as to the scope of the claims. In re Steele, 134 USPQ 292. When no reasonably definite meaning can be ascribed to certain terms in a claim, the subject matter does not become obvious, but rather the claim becomes indefinite. In re Wilson, 165 USPQ 494.
Regarding claim 18, which recites “wherein the one or more medical device separates a tissue sample from dislodged cells obtained during a biopsy”, which renders the claim indefinite because claim 15 is drawn to packaging for medical devices, and the introduction of how the product stored within the medical devices unrelated to the packaging of medical devices, as such, the examiner is unable to determine exactly what the applicant is claiming in relation to claim 15.
While the Examiner might speculate as to what is meant by the claim language, the uncertainty provides the Examiner with no proper basis for making the comparison between that which is claimed and the prior art. Rejections under 35 U.S.C. § 103 should not be based upon considerable speculation as to the meaning of terms employed and assumptions as to the scope of the claims. In re Steele, 134 USPQ 292. When no reasonably definite meaning can be ascribed to certain terms in a claim, the subject matter does not become obvious, but rather the claim becomes indefinite. In re Wilson, 165 USPQ 494.
Regarding claim 19, which recites “wherein the one or more medical device includes a buffer container and a sample collection container, the buffer container removeable from the sample collection container while the sample collection container is help upright within the at least one cutout”, which renders the claim indefinite because claim 15 is drawn to packaging for medical devices, and the introduction of how the product stored within the medical devices unrelated to the packaging of medical devices, as such, the examiner is unable to determine exactly what the applicant is claiming in relation to claim 15.
While the Examiner might speculate as to what is meant by the claim language, the uncertainty provides the Examiner with no proper basis for making the comparison between that which is claimed and the prior art. Rejections under 35 U.S.C. § 103 should not be based upon considerable speculation as to the meaning of terms employed and assumptions as to the scope of the claims. In re Steele, 134 USPQ 292. When no reasonably definite meaning can be ascribed to certain terms in a claim, the subject matter does not become obvious, but rather the claim becomes indefinite. In re Wilson, 165 USPQ 494.
Regarding claim 20, which recites “wherein the one or more medical device includes a plurality of medical devices that are each individually sealed in individual device packaging”, which renders the claim indefinite because claim 15 is drawn to packaging for medical devices, and the claim language requires that every medical device is a plurality of devices and that each device must be sealed in individual packages, the examiner is unable to determine if the applicant is claiming that each medical device 100 is broken down into more medical devices 100 or not, as such, the examiner is unable to determine exactly what the applicant is claiming in relation to claim 15.
While the Examiner might speculate as to what is meant by the claim language, the uncertainty provides the Examiner with no proper basis for making the comparison between that which is claimed and the prior art. Rejections under 35 U.S.C. § 103 should not be based upon considerable speculation as to the meaning of terms employed and assumptions as to the scope of the claims. In re Steele, 134 USPQ 292. When no reasonably definite meaning can be ascribed to certain terms in a claim, the subject matter does not become obvious, but rather the claim becomes indefinite. In re Wilson, 165 USPQ 494.
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, 3-8, 10-11 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Specker (US Pub 20100276306).
Regarding Claim 1, Specker discloses a packaging container (1-Fig. 1) for one or more medical device (30-Fig. 2, the examiner cites that the specification has the medical device as a vial or container, as such, the examiner is going to interpret the medical device as package medical goods, and paragraph [0001], packing of pharmaceuticals in ampules, vials and bottles), the packaging container comprising:
an inner part (32-Fig. 3) including a rack (16-18-Fig. 3) surface having at least one cutout (Fig. 3, recess 10 is in the form of a cutout) configured to hold the one or more medical device (Fig. 1, multiple bottles 30) both during shipping and upright during use of the one or more medical device (Figs. 1-2 and paragraph [0001], packaged bottles are capable of being shipped and the packaging can propped to hold the bottles 30 upright); and
an outer part (4 and 5-Fig. 2) enclosing the inner part (Fig. 2, sections 4 and 5 are enclosing the walls 16-17), the outer part including a tear line (45-48 of Fig. 4) enabling a user to remove a portion thereof (Fig. 2, unit 14 has been separated from unit 14’) and expose the rack surface of the inner part so that the user can use the one or more medical device while the one or more medical device is held upright by the inner part (Fig. 4, separation lines 45-48 allows user to separate section 5, which enable the user to access the bottles 30 and the packaging can be placed in an upright orientation).
Regarding Claim 3, Specker discloses wherein the at least one cutout is formed as an aperture (10-Fig. 3) in the rack surface.
Regarding Claim 4, Specker discloses wherein the at least one cutout includes a center portion (Fig. 3, portion of 10 within 16) and at least one side portion (Fig. 3, portion of 10 within 18), the at least one side portion forming an aperture in combination with the center portion (Fig. 3, 10 is continuous between 16 and 18), the at least one side portion extending outwardly from the center portion in a first direction and being smaller than the center portion in a second direction perpendicular to the first direction (Fig. 3, the narrowing of the section 10 within 18).
Regarding Claim 5, Specker discloses wherein the outer part includes an upper portion (5-Fig. 2) and a lower portion (4-Fig. 2), the upper portion is configured to be separated from the lower portion using the tear line (Figs. 1-4, sections 4 and 5 of each unit 14 are capable of being separated from one another by lines 45-48) and the lower portion contains the inner part when the upper portion is removed using the tear line (Figs. 1-4, section 5 of unit 14 is separated from section 4 of unit 14).
Regarding Claim 6, Specker discloses wherein the inner part includes an upper rack surface (Fig. 3, surfaces surrounding recess 11) and a lower rack surface (Fig. 3, the surfaces surrounding recess 10),
the upper rack surface includes at least one upper cutout configured to hold the one or more medical device upright during use of the one or more medical device (Fig. 2, recess 11 is in the form of a cutout and retains bottle 30, wherein the packaging is capable of holding bottle 30 in an upright position), and
the lower rack surface includes at least one lower cutout (Fig. 3, recess 10 is in the form of a cutout) aligned with the upper cutout in a vertical direction (Fig. 2, wherein two of the walls defining the recess 10 and 11 are vertical and one is horizontal, in that when unit 14 is held upright the horizontal walls are aligned), the at least one lower cutout configured to hold the one or more medical device upright during use of the one or more medical device (Fig. 2, recess 10 is in the form of a cutout and retains bottle 30, wherein the packaging is capable of holding bottle 30 in an upright position).
Regarding Claim 7, Specker discloses wherein the rack surface includes a plurality of cutouts (Fig. 3, recess 10 and 11) configured to each hold a medical device upright both during shipping and during use of the medical device (Fig. 2, unit 14 is capable of hold each bottle 30 in shipping and in the upright position).
Regarding Claim 8, Specker discloses a packaging container (14-Fig. 2) for one or more medical device (30-Fig. 2), the packaging container comprising:
an inner part (32-Fig. 3) formed by a first single sheet of cardboard (Fig. 3 and paragraph [0048], blank 32 is a single sheet cardboard) folded along a plurality of fold lines (Fig. 3) to form at least a rack surface (Fig. 2, the surfaces defining recess 10) configured to hold the one or more medical device both during shipping and upright during use of the one or more medical device (Fig. 2, bottle 30 is retained in recess 10 by folded blank 32, wherein the folded blank is capable of holding bottle 30 during shipping and in the upright position); and
an outer part (1-Fig. 1) formed by a second single sheet of cardboard (Fig. 5) folded along a plurality of fold lines (Fig. 5 folded into the box 1 of Fig. 1) to form an enclosure for the inner part (Fig. 1), the outer part including an upper portion (2-Fig. 1) and a lower portion (Fig. 1, portion of box 1 which surrounds insert 3), the upper portion configured to be separated from the lower portion to expose the inner part (Fig. 1, lid is open and separated from the rest of the box).
Regarding claim 10, wherein the inner part includes at least one cutout (10-Fig. 3) configured to hold the one or more medical device upright during use of the one or more medical device (Fig. 2, the examiner notes that the structure defining recess 10 is capable of holding bottle 30 in an upright position).
Regarding Claim 11, Specker discloses wherein the at least one cutout includes a center portion (Fig. 3, portion of 10 within 16) and at least one side portion (Fig. 3, portion of 10 within 18), the at least one side portion forming an aperture in combination with the center portion (Fig. 3, 10 is continuous between 16 and 18), the at least one side portion extending outwardly from the center portion in a first direction and being smaller than the center portion in a second direction perpendicular to the first direction (Fig. 3, the narrowing of the section 10 within 18).
Regarding Claim 13, Specker discloses wherein the inner part includes an upper rack surface (Fig. 3, surfaces surrounding recess 11) and a lower rack surface (Fig. 3, the surfaces surrounding recess 10),
the upper rack surface includes at least one upper cutout configured to hold the one or more medical device upright during use of the one or more medical device (Fig. 2, recess 11 is in the form of a cutout and retains bottle 30, wherein the packaging is capable of holding bottle 30 in an upright position), and
the lower rack surface includes at least one lower cutout (Fig. 3, recess 10 is in the form of a cutout) aligned with the upper cutout in a vertical direction (Fig. 2, wherein two of the walls defining the recess 10 and 11 are vertical and one is horizontal, in that when unit 14 is held upright the horizontal walls are aligned), the at least one lower cutout configured to hold the one or more medical device upright during use of the one or more medical device (Fig. 2, recess 10 is in the form of a cutout and retains bottle 30, wherein the packaging is capable of holding bottle 30 in an upright position).
Regarding Claim 14, Specker discloses wherein the rack surface includes a plurality of cutouts (Fig. 3, recess 10 and 11) configured to each hold a medical device upright both during shipping and during use of the medical device (Fig. 2, unit 14 is capable of hold each bottle 30 in shipping and in the upright position).
Regarding Claim 15, Specker discloses a medical package (the packaging of Fig. 1) comprising:
one or more medical device (Fig. 1, multiple bottles 30); and
a packaging container (3-Fig. 1) containing the one or more medical device therein, the packaging container having at least one cutout (10-Fig. 3) configured to hold the one or more medical device both during shipping and upright during use of the one or more medical device (Fig. 2, unit 14 is capable of hold each bottle 30 in shipping and in the upright position).
Regarding Claim 16, Specker discloses wherein the packaging container includes an inner part (32-Fig. 3) and an outer part (4 and 5-Fig. 2),
the inner part including a rack (16-18-Fig. 3) surface having at least one cutout (Fig. 3, recess 10 is in the form of a cutout) configured to hold the one or more medical device (Fig. 1, multiple bottles 30) both during shipping and upright during use of the one or more medical device (Figs. 1-2 and paragraph [0001], packaged bottles are capable of being shipped and the packaging can propped to hold the bottles 30 upright); and
the outer part enclosing the inner part (Fig. 2, sections 4 and 5 are enclosing the walls 16-17), the outer part including a tear line (45-48 of Fig. 4) enabling a user to remove a portion thereof (Fig. 2, unit 14 has been separated from unit 14’) and expose the rack surface of the inner part so that the user can use the one or more medical device while the one or more medical device is held upright by the inner part (Fig. 4, separation lines 45-48 allows user to separate section 5, which enable the user to access the bottles 30 and the packaging can be placed in an upright orientation).
Regarding Claim 17, Specker discloses wherein the packaging container includes an inner part (32-Fig. 3) and an outer part (4 and 5-Fig. 2),
an inner part (32-Fig. 3) formed by a first single sheet of cardboard (Fig. 3 and paragraph [0048], blank 32 is a single sheet cardboard) folded along a plurality of fold lines (Fig. 3) to form at least a rack surface (Fig. 2, the surfaces defining recess 10) configured to hold the one or more medical device both during shipping and upright during use of the one or more medical device (Fig. 2, bottle 30 is retained in recess 10 by folded blank 32, wherein the folded blank is capable of holding bottle 30 during shipping and in the upright position); and
an outer part (1-Fig. 1) formed by a second single sheet of cardboard (Fig. 5) folded along a plurality of fold lines (Fig. 5 folded into the box 1 of Fig. 1) to form an enclosure for the inner part (Fig. 1), the outer part including an upper portion (2-Fig. 1) and a lower portion (Fig. 1, portion of box 1 which surrounds insert 3), the upper portion configured to be separated from the lower portion to expose the inner part (Fig. 1, lid is open and separated from the rest of the box).
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.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Specker (US Pub 20100276306) and further in view of Hanahan (USP 3765044).
Regarding claim 12, Specker disclose the outer and lower portions in the parent claim.
However, Specker is silent regarding wherein the outer part includes a tear line, and the upper portion is configured to be removed from the lower portion using the tear line.
Hanahan teaches wherein an outer part (Fig. 1, blank 20 has an outer part) includes a tear line (42-Fig. 2), and an upper portion (Fig. 2, portion of container 39 above line 42) is configured to be removed from a lower portion (Fig. 2, portion of container 39 below line 42) using the tear line (Fig. 3, container 39 lacks the upper portion above line 42).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s invention, to have modified the outer portion as disclosed by Specker, to have incorporated the tear line as taught by Hanahan, so to allow the top of a container to be removed, in order to allow the contents of the container to be accessed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to Notice of Reference Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT HOWELL whose telephone number is (571)270-5945. The examiner can normally be reached M-F, 0800 - 1500.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thanh Truong can be reached at 571-272-4472. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT A HOWELL/Examiner, Art Unit 3731
/JOSHUA G KOTIS/Examiner, Art Unit 3731