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 .
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1-14) and Species 3 (Figures 3A-3B) in the reply filed on 11/10/2025 is acknowledged. In the reply, Applicant indicated that claims 1-14 read on the elected species. The traversal is on the grounds that Group I is drawn to a package and Group II is drawn to a method of using the package of Group I, in particular assembling a sealed sterile package according to claim 1 containing at least one medical device. Since Group II is drawn to a process of use of the product of Group I, there is unity of intervention between Groups I and II. The traversal is on the grounds that Examiner fails to properly establish why there would be a serious search and/or examination burden. From the figures, it is clear that the different embodiments of the sample collection container have similar shapes and relative arrangements of their respective features This is not found persuasive because, as described in the restriction requirement of 10/7/2025, the technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Khan (US 2019/0110852). Furthermore, the species require a different field of search (e.g., employing different search strategies or search queries for the different structural features (e.g. different first web structures, different second web structures, different interfaces between the webs, etc.) of the distinct species). The requirement is still deemed proper and is therefore made FINAL. Claims 15-19 are withdrawn from consideration.
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 2 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 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner suggests replacing “such as” with “comprising”.
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)(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.
Claims 1, 3-6, 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khan (US 2019/0110852).
Regarding claim 1, Khan discloses a package (See Fig. 2) capable of containing at least one medical device, comprising: at least one first web (lid - See Fig. 2 labeled below) comprising a natural-fiber material (pulp material – [0050]); and at least one second web (body- See Fig. 2 labeled below) comprising the natural-fiber material (pulp material – [0050]), wherein the at least one second web comprises at least one cavity (See Fig. 2 labeled below) sized capable of containing at least one medical device, wherein the at least one first web is connected to the at least one second web to provide a sterile barrier preventing microbial ingress (See [0034]) to the at least one medical device through the package.
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Regarding claim 3, Khan discloses the package comprises a renewable material comprising paper.
Regarding claim 4, Khan discloses the package comprises materials that are compatible with a steam sterilization processes (See [0025]).
Regarding claim 5, the determination of patentability in a product-by-process claim is based on the product itself, even though the claim may be limited and defined by the process. That is, the product in such a claim is unpatentable if it is the same as or obvious from the product of the prior art, even if the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir. 1985). A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. (Same cite as above).
Regarding claim 6, Khan discloses the at least one second web has a three- dimensional shape (See Figs. 1-2).
Regarding claim 12, Khan discloses the at least one first web is connected to the at least one second web by an interference engagement (at 30/20 in Fig. 2 – See [0055]), without adhesive.
Regarding claim 14, Khan discloses the first web comprises a depression comprising a peripheral sloped surface (to the right of 30 in Fig. 2) configured to contact a sloped surface (between 8 and 20 in Fig. 2) of the at least one cavity of the second web to form the interference engagement between the at least one first web and the at least one second web.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Khan (US 2019/0110852), as applied to claim 1, in view of Mehta et al. (US 10,384,827). As described above, Khan discloses the claimed invention except for the express disclosure that the package is fully recyclable in a single recycling stream. However, Mehta teaches it is well known in the art for a pulp-based packaging to be recyclable in a single stream recycling process without the need for additional pre-processing or sorting (See column 5, lines 20-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the packaging of Khan to be recyclable in a single recycling stream as taught by Mehta in order to eliminate the need for additional pre-processing or sorting.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Khan (US 2019/0110852), as applied to claim 1, in view of Tigner (US 3,454,158). As described above, Khan discloses the claimed invention except for the webs being connected by an adhesive. However, Tigner teaches a package (See Figs. 1-2) comprising a first web (lid at 20) and a second web (base at 18) connected to one another (at 48/38 in Fig. 2), wherein the connection is provided with an adhesive (resealable adhesive), for the purpose of allowing the webs to be securely sealed to one another while allowing for resealability. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the packaging of Khan with an adhexive at the connection between the webs as taught by Tigner in order to allow for a more secure connection between the webs while still allowing for resealability.
Further regarding claim 8, Khan-Tigner discloses the at least one second web comprises a flat contour (at the top of 20 in Fig. 2 in Khan), and wherein the adhesive seals the flat contour of the at least one second web to a flat portion of an inner surface (inner surface of 30 in Fig. 2) of the at least one first web.
Further regarding claim 9, Tigner teaches the adhesive is sealed by heat sealing.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Khan (US 2019/0110852) in view of Tigner (US 3,454,158) as applied to claim 7 above, and further in view of Bohrer (US 2013/0260106). As described above, Khan-Tigner discloses the claimed invention except for the express disclosure of the specifics of the adhesive. However, Bohrer teaches it is well known in the art for a packaging adhesive to be water soluble to be washed away during a recycling process (See [0044]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adhesive of Khan-Tigner to be water soluble to be washed away during a recycling process as taught by Bohrer in order to allow for easier recycling.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Khan (US 2019/0110852), as applied to claim 1, in view of Jondal (US 2023/0182974). As described above, Khan discloses the claimed invention except for the inner surfaces of the webs having rough areas. However, Jondal teaches it is well known to provide the inner surfaces of the lid and base of a package with rough surface texture for the purpose of inceasing the amount of friction between the inner interface surfaces for making it harder to open the package ([0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified inner surfaces of the webs of Khan at the connection interfaces with rough textures as taught by Jondal in order to provide a more secure connection between the webs when closed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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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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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735