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 .
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.
Election/Restrictions
Applicant’s election with traverse in the reply filed on 15 April 2026 is acknowledged.
The restriction requirement as set forth in the Office action mailed on 20 February 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 19 is 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 19, the language, “the gas-permeable seal includes a first mating feature on the first packaging member and a second mating feature on the second packaging member” is indefinite. What is a mating feature? Is the mating feature more than just a seal surface? What makes something a “feature”? In addition, the seal is where the two packaging members are fused together. With this in mind, the mating features are of the packaging members and not part of the seal. In other words, the seal is located in the area of mating features of the packaging members.
Claim Rejections - 35 USC § 102
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, 3, 4, 6, 8, 15, 16, 17, and 19 are rejected under 35 U.S.C. 35 U.S.C. 102(a)(1) as being anticipated by Brugger et al. (US 5922162).
Regarding claim 1, Brugger discloses medical device packaging that permits gas sterilization, the medical device packaging 26, fig. 3, comprising:
a first packaging member (sheet 8 on first side); and
a second packaging member (sheet 8 on second side) attached to the first packaging member with a gas- permeable seal at 28, the first packaging member and the second packaging member forming an inner cavity to house a medical device, col. 3: 57-end,
the gas-permeable seal including, see fig. 5, pattern 2, a first seal segment, first row of dashed seals, and a second seal segment, second/middle row of dashed seals, spaced apart from the first seal segment and more proximal to the inner cavity than the first seal segment, the first seal segment including a first opening and the second seal segment including a second opening offset from the first opening by a distance, the gas-permeable seal including a channel formed from the first and second seal segments and the first and second openings, the channel being a single path that permits gas passage from an external environment to the inner cavity.
Regarding claim 3, Brugger discloses the first and second packaging members are formed from the same sheet 8, that is folded along one side at 18, fig. 3, col. 3: 57-end. As such, the first and second packaging members are formed of the same material.
Regarding claim 4, referring to the embodiment of fig. 8, Brugger further discloses an embodiment with a flat pouch with weld seals on three sides, all of a tortuous path, col. 4: 39-55, the seals on opposing sides of the flat pouch, along with the 2nd representative pattern 52 seen in fig. 5, col. 4: 34-28, provides a first opening on one side of the medical device packaging and a second opening of the second seal segment on another side of the medical device packaging.
Regarding claim 6, Brugger discloses, fig. 5, pattern 2, the gas-permeable seal includes a third seal segment, third row of dashed seals, that is spaced apart from the second seal segment, the third seal segment being located more proximal to the inner cavity than the second seal segment.
Regarding claim 8, Brugger discloses, fig. 5, pattern 2, that a spacing between the first seal segment and the second seal segment is substantially the same as a spacing between the second seal segment and the third seal segment.
Regarding claim 15, Brugger discloses medical device packaging that permits gas sterilization, the medical device packaging comprising, fig. 7, col. 4: 32-40:
a first packaging member (non-permeable lid stock); and
a second packaging member (thermoformed tray) attached to the first packaging member with a gas- permeable seal at 50, the first packaging member and the second packaging member forming an inner cavity to house a medical device,
the gas-permeable seal including a channel, see fig. 7 and annotated fig. 8, to permit gas passage through the gas-permeable seal, the channel including a first opening to an external environment on one side of the medical device packaging and a second opening to the inner cavity on a second side of the medical device packaging.
Regarding claims 16 and 17, Reference annotated fig. 8 of Brugger, having the same seal as fig. 7 but the lines are more clearly drawn in fig. 8, the seal includes elongate segments that are both parallel to the edge of the packaging (the edge is seen as a solid dark line), and elongate segments that are perpendicular/orthogonal to the edge of the packaging.
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Regarding claim 19, the word “feature” has no special meaning and the generic language “mating feature” is not combined with functional language such that structure from the specification should be read into the claim. For the purposes of examination, “feature” is interpreted broadly. Each of the first and second packaging members have inner sides around their respective perimeters which are “features” of the packaging members where the seal is formed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Brugger as applied to claim 1 above, and further in view of Schuster (US 4203520).
Regarding claim 2, the references applied above teach all of claim 1, as applied above. Brugger does not mention the transparency of the packaging.
Schuster is analogous art in regard to in regard to packaging for medical articles and teaches a package with a tortuous path that prevents entry of contaminating microorganisms see Abstract and fig. 1-3 and 9, col. 4: 1-15. Schuster further teaches that the packaging be made transparent for unobstructed view of the contents housed in the packaging, col. 3: 15-19.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brugger to provide transparent packaging material in order to allow unobstructed view of the contents of the packaging as per the teaching of Schuster.
Claim(s) 5, 6, 9-14, and 18, are rejected under 35 U.S.C. 103 as being unpatentable over Brugger et al. (US 5922162).
Regarding claims 5, 9-11, and 18, Brugger discloses a medical device packaging that permits gas sterilization, the medical device packaging 26, fig. 3, comprising:
a first packaging member (sheet on first side); and
a second packaging member (sheet on second side) attached to the first packaging member with a gas- permeable seal at 28, the first packaging member and the second packaging member forming an inner cavity to house a medical device, col. 3: 57-end,
the gas-permeable seal including, see fig. 5, pattern 2, a first seal segment, first row of dashed seals, and a second seal segment, second/middle row of dashed seals, spaced apart from the first seal segment and more proximal to the inner cavity than the first seal segment,
the first seal segment including, as seen in pattern 2, fig. 5, a first opening and the second seal segment including a second opening offset from the first opening by a distance, the gas-permeable seal including a channel formed from the first and second seal segments and the first and second openings, the channel being a single path that permits gas passage from an external environment to the inner cavity. Although there are a plurality of paths, each “channel” has a single path, the other channels have their own path.
Brugger does not disclose any particular length or diameter of the disclosed channel; no particular cross-section is disclosed.
However, Brugger discloses that changing the shape, length, and diameter (designing) of tortuous or labyrinthine passages for preventing passage of bacteria or viruses is well known in the art, col. 1: 30-35.
With this in mind, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the channels of Brugger with a cross-sectional area in a range of 7.8 x 10-12 square meters to 1.26 x 10-11 square meters ([0100] of the instant invention) or the length of 1 x 10-7 meters because Applicant has not disclosed that the particular cross-sections claimed provides any new advantage, is used for a particular purpose, other than the known purpose of preventing passage of bacteria or viruses or solves a stated problem other than that already solved by the prior art. One of ordinary skill in the art, furthermore, would have expected Brugger’s channels, and applicant’s invention, to perform equally well with either the undisclosed channel dimensions or the claimed dimensions because both cross-sections perform the same function of preventing the passage of viruses and bacteria.
Therefore, it would have been prima facie obvious to modify Brugger to obtain the invention as specified in claims 5, 9, and 18, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Brugger.
Regarding claims 6 and 12, Brugger discloses, fig. 5, pattern 2, the gas-permeable seal includes a third seal segment, third row of dashed seals, that is spaced apart from the second seal segment, the third seal segment being located more proximal to the inner cavity than the second seal segment.
Regarding claims 7 and 13, the references applied above teach all of claims 6 and 12, as applied above. The references applied above teach uniform spacing, as applied above, not different spacing between seal segments.
However, there are two possibilities, either the spacing between the first and second seal the same as a spacing between the second seal segment and the third seal segment, or the spacing between the first seal segment and the second seal segment is different than a spacing between the second seal segment and the third seal segment. Applicant has claimed both possibilities.
With this in mind, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try a configuration where the spacing between the first and second seals is either the same or different from the spacing between the second and third seals in order to discover which spacing better prevents passage of bacteria and viruses.
Regarding claim 14, Brugger discloses, fig. 5, pattern 2, that a spacing between the first seal segment and the second seal segment is substantially the same as a spacing between the second seal segment and the third seal segment.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Brugger as applied to claim 15 above, in view of Raley et al. (US 4550546).
Regarding claim 20, Brugger teaches all of claim 15, as applied above. Brugger does not teach holes in the packaging members.
Raley is analogous art in regard to sealed packages for sterilizing medical items, col. 1: 15-25.
Raley teaches, fig. 1 and 2, a first packaging member 10 formed from a first layer 11a, a second layer (third packaging member) 11b and a second packaging member (not numbered, seen in fig. 4) attached to the first packaging member with a seal at the edges 24,
the first packaging member and the second packaging member forming an inner cavity to house a device 23 to be sterilized, col. 2: 25-40,
The first and second layers of the first packaging member 10 of Raley each have holes, the layers are positioned such that the holes of each layer are offset from one another, fig. 1. As seen in fig. 2, the misalignment of the holes form a tortuous channel to the inner cavity through the one or more first holes, a spacing between the first and third packaging members, and the one or more second holes, col. 2: 20-37.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brugger to include the additional tortuous paths on the surfaces of the packaging in order to allow the item to be sterilized from all sides of the packaged item.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLIE L IMPINK whose telephone number is (571)270-1705. The examiner can normally be reached Monday-Friday (7:30-3:30).
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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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MOLLIE LLEWELLYN IMPINK
Primary Examiner
Art Unit 3799
/MOLLIE IMPINK/Primary Examiner, Art Unit 3799
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