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 without traverse of Group I, Species 2 (corresponding to, e.g., Figs. 3A-4D) in the reply filed on 12 February 2025 was previously acknowledged.
Claims 9, 12-18 and 20 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the aforementioned reply.
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 1-5, 11, 19 and 21-27 are rejected 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. Any claim not specifically mentioned is rejected based on its dependence.
Claim 1 have been previously been amended to recite “the compressible portion is manually compressible” (emphasis added). Examiner is still unable to locate support of this limitation in the original disclosure. Nevertheless, the claims are examined as written. See below for further analysis and response to Applicant’s arguments.
Clarification and/or correction is requested.
Claim Interpretation
Claim 1 preamble limitation “ampoule” and feature “ampoule” mentioned in the body of the claim but not explicitly recited as a feature of the claimed invention has been considered a feature of the claimed invention based on its presence in the preamble and repetition in the body of the claims, as set forth in MPEP 2111.02, in accordance with Applicant’s most recent arguments. The ampoule and its inner wall/surface are considered to disclose a fundamental characteristic of the claimed invention that is properly construed as a limitation and feature of the claim. Thus, the claimed invention is essentially a tray and ampoule functioning as claimed.
Response to Arguments
Applicants’ arguments filed 17 June 2026 have been fully considered and are addressed below
The new, amended drawings (and related specification amendments) have been accepted. Thus, objections and rejection related to the same have been withdrawn. Examiner notes that in the instant case, it was not clear whether the features were shown without the corresponding labels. Examiner appreciates Applicants’ assistance in making the record clear such that Examiner and other can understand Applicant’s claimed invention.
Applicant has argued that the term “manually” is supported by the original disclosure. Examiner does not agree. First, Examiner notes that the invitation to clarify was not an invitation to add subject matter not originally disclosed. Second, Examiner acknowledges and appreciates the relevant portions of the specification pointed out that are believed to provide necessary support for incorporation of the term in the claimed invention. However, Examiner finds that there is no proof that compression of trays is or must be done “manually”, since manually or equivalent is not used in the original disclosure explicitly or implicitly. The possibility of manual compression is not sufficient. Therefore, a broadest reasonable interpretation of the term has been used in consideration of the specification. In particular, the aforementioned relevant portions have been considered in interpreting relevant language. While it is possible that the feature(s) are manually compressible (i.e. compressible by a hand and not by a machine, as defined by Merriam-Webster) there is no clear evidence that the compression is actually done manually, rather than with a machine or with machine assistance. In order to expedite examination, Examiner suggest deleting “manually” as it also does not appear to be relevant to patentability at this point with respect to cited prior art.
Applicant has argued that as written the ampoule is a feature of the claimed invention. Previously, Examiner did not interpret the ampoule as a feature of the claimed invention and Applicant did not traverse such an interpretation, until now. In accordance with Applicant’s amendments and arguments, Examiner has reconsidered interpretation and now considers the ampoule a feature of the claimed invention. See above modified claim interpretation.
Regarding previous prior art rejections, interpretations of the prior art, and Applicant’s arguments regarding the same, see below. Although, no prior art rejections remain, Examiner does not necessarily agree with all of Applicants’ arguments and interpretations.
Examiner does not find “accordion-like surface having a ridge direction and a fold direction” precludes a sinusoidal shaped surface which is accordion-like in that it has a zig-zag, waveform nature. The key word being “like” and the circumstance being that no particular degree (e.g. an angle or acceptable radius of curvature) of “accordion-like” is claimed. Also see reference USP 12,226,726 as evidence where various waveform shapes are discussed and a shape similar to Applicant’s is called sinusoidal.
Examiner does not agree that a “tray” and “shelf” inherently have mutually exclusive characteristics when broadly claimed. They both are capable of holding. Furthermore, a shelf may have a lip and a tray may not function as a movable article. A tray may be stationary. Naming something a tray does not make it movable, nor does it require a lip or raised circumferential edge.
Applicants have also provided extensive findings based on what one of ordinary skill in the art would assume about their disclosure or prior art disclosures. In general, Examiner has used what is actually set forth in the disclosures except where specific supporting evidence has been provided. For example, Applicant’s characterization of Hendrix beyond what was originally disclosed has not been considered as part of the disclosure. In particular, Examiner notes that silence is not necessarily a teaching away.
Nevertheless, in accordance with Applicant’s arguments and amendments requiring the ampoule to be a feature of the claimed invention and contact thereof is a required feature of the claimed invention (i.e. “when the manual compression is released, the compressible portion expands the tray again an inner wall of the ampoule”), Examiner finds that claim 1 distinguishes over the relied upon prior art. See below for closest and most relevant prior art.
Gartner discloses a tray and ampoule configuration, with an accordion-surface as claimed, but does not address teachings regarding insertion and removal in association with compression and relaxation of the tray as claimed.
Baum discloses disks/trays that are press-fit to an interior surface of a vessel/ampoule.
Lei, Wang, Okabe disclose accordion-like surfaces of a tray.
Hendrix discloses compressing a tray to position it in an ampoule in order to increase physical contact. A tool may be used to provide the compression, whether or not positioning is performed manually using the tool is not mentioned. Hendrix does not disclose the compression and expansion as claimed in conjunction with insertion or removal from the ampoule
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. USP 12,226,726 relates to accordion-like surfaces.
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 KARLA MOORE whose telephone number is (571)272-1440. The examiner can normally be reached Monday-Friday, 9am-6pm EST.
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/KARLA A MOORE/Primary Examiner, Art Unit 1716
