The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 1 is objected to because of the following informalities: the last part of the added “wherein the probe is specific to the marker” language in claim 1 is a repeat of language found in element (b) of claim 1. Appropriate correction is required.
Claims 1 and 3-20 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. With respect to claim 1, it is not clear how the sample type is to be interpreted relative to requiring any additional structure of claim 1. Is there a difference in the structure that is dependent on the sample type? Is the designation the sample applicant’s attempt to require some structure to obtain a sample of the respective samples” Alternatively, is the sample type designation applicant’s attempt to limit the type of probes that is contained in the auxiliary chamber? Alternatively, is the sample type simply non-limiting language. For examination purposes, since there is no clear link either additional structure that might be required or the probe in the auxiliary chamber, the language will be treated as non-limiting on the structure of the article being claimed.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 11,903,695. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are of a scope that totally encompasses a majority of the patented claims. The addition of the sample type is being treated as not having any patentable moment as explained above. Thus one cannot practice the patented claims without also practicing the instant claims.
Applicant's arguments filed September 12, 2025 have been fully considered but they are not persuasive. In response to the claim changes the objection to claim 17 and the statutory double patenting rejection has been withdrawn, a new claim objection has been made relative to the changes in claim 1, the rejection under 35 U.S.C. 112(b) has been modified to reflect the claim changes and the non-statutory double patenting rejection has been slightly modified to reflect claim changes. The arguments are moot with respect to the new and/or withdrawn objections/rejections.
With respect to the clarity of previous claim 2 and instant claim 1, claim 1 is drawn to an article or device having structure. A proper limitation having patentable moment in such a claim is one that defines the structure of the article or device. In the instant claim, the sample is not a positively recited element of the article or device. Put another way, claim 1 does not require the sample to be present in the article or device. As such, defining the sample type does not provide a structural limitation. However, the sample type could point to a structural limitation if there is structure needed to handle and/or operate the article or device on a particular sample type or if each sample type was limited in the probes that could be used for that particular sample type. If such limitations are found in the specification, examiner notes that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus if applicant intended the recitation of sample type to provide some further definition of the types of probes in the article and/or require some additional structure to handle/interact with a certain sample type, it is not clear what further structure was intended by the sample type recitation. That is an issue whether the sample type recitation is in a dependent claim or the independent claim. Thus the problem that applicant was attempting to correct by incorporating that limitation from claim 2 into claim 1 did not solve the clarity problem and the argument is not persuasive.
Relative to the non-statutory double-patenting rejection, while examiner recognizes that there might be advantages to waiting until the other rejections are resolved, that rejection should be considered by applicant with each office action from the examiner. In particular, if applicant feels that a particular claim change and/or dependent claim included in the rejection contains language that overcomes the rejection or is outside of the reasonable scope of the rejection, it would be appropriate to provide that argument to direct examiner’s consideration of the rejection to the claims in applicant’s response. Alternatively, it would be appropriate for applicant to consider whether there are claim amendments that applicant is willing to make which would overcome that rejection. If there are no such amendments, then there is little if any reason to wait until the other rejections are resolved. For that reason, the non-statutory double-patenting rejection will not be held in abeyance until the other rejections have been resolved.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited art is related to structures in which reagents and solvents are contained in chambers separated from each other by a frangible barrier or which measure components of a breath sample.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached 1st week Monday-Thursday, 2nd week Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571)272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARLEN SODERQUIST/Primary Examiner, Art Unit 1797