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 .
Response to Arguments
The Applicant has provided a response, dated 7/23/2026. In the response, the Applicant has provided new claims 21-30, and arguments directed to the previous rejections.
On page 5 of the Applicant’s Arguments, the Applicant points to elements of the instant specification to disclose proper written description for the limitation provided in claim 20. This description appears reasonable for a disclosure under 35 USC 112(a), and the rejection of the claim has been withdrawn.
On page 6 of the Applicant’s Arguments, the Applicant states that Nicholls fails to teach simultaneous administration. While this is entirely true for a method, the Applicant has presented no evidence to suggest that a machine, that is under computer control, is incapable of administering compounds separately or simultaneously. The Applicant has shown no physical limitations on the apparatus of Nicholls that would prevent it from being capable of simultaneous administration; aside from unpatentable programming language, there does not appear to be any structural elements that would forbid Nicholls’ apparatus from being capable of performing simultaneous administration. It should be noted that the rejection is based on the apparatus of Nicholls, wherein Nicholls shows that the apparatus can be adapted for the claimed method. The apparatus of Nicholls is a commercially available apparatus, and there is no reasonable expectation to think that Nicholls would disclose all of the technical specifications of a commercially available apparatus. If the Applicant can show that the apparatus of Nicholls is wholly incapable of simultaneous administration, the rejection would need to be reassessed, but currently, it appears as though the apparatus that Nicholls uses should be programmable to administer compounds simultaneously. This is why the rejection is based upon both 35 USC 102 and 35 USC 103. Although not explicitly stated, it appears reasonable to suggest that the apparatus of Nicholls is capable of the claimed actions, it is unclear if the claimed action is a default action, or an action that must be programmed by the user.
On page 7 of the Applicant’s Arguments, the Applicant states that the rejection provides for “impermissible hindsight,” and ignores a “teaching away.” With respect to the former, the claims are drawn to an apparatus, per se, wherein the apparatus of Nicholls appears as though it should be capable of the claimed method; the Applicant has provided no evidence to suggest that the commercially available apparatus of Nicholls cannot perform simultaneous administration. It should also be highlighted that both Nicholls and the instant specification appear to perform the claimed method on the same device developed by Seahorse Bioscience, and there does not appear to be any adaptations from the commercially available device described in the specification. This would suggest that Nicholls must have anticipated the claimed device.
With respect to the claim of “teaching away.” First, a requirement for “teaching away” must be clear, in the sense that the prior art reference must clearly state a solution will not work. See MPEP 2145(X)(D)(1). Second, the Applicant is claiming a method step on a physical device. Even if Nicholls explicitly discouraged simultaneous administration, the Applicant has provided no evidence to suggest that this administration is impossible on the device of Nicholls. The Applicant is reminded that the claims are drawn to a physical device, wherein said device could potentially be used for a number of different methods.
With respect to the obviousness of applying methods to the device, take for example, high pressure liquid chromatography (HPLC) devices. These have been used for decades, wherein artisans have devised innumerable methods of using the device for different purposes. In this situation, the HPLC artisan knows that flow rates can be modified, any number of stationary phases can be used, variable temperatures can be programmed, and different eluents can be used, all of which are provided to elicit different types of separations; however, the device continues to be the same HPLC device, regardless of what type of method is performed on it. In the instant situation, it appears as though the claimed method can be used on the device of Nicholls. This assessment is supported by the fact that the applied examples of the instant invention appear to use the same device as Nicholls, and there does not appear to be anything in the instant specification for the modification of the commercially available device. All arguments of obviousness revolve around the fact that the claimed device, the device of Nicholls, and that of the applied examples all appear to be the same thing. As such, the device appears to be anticipated, whereas specific methods of using the device would be obvious to the ordinary artisan, because the instruction booklet of the device would provide the artisan with clues as to accomplishing particular tasks.
On page 7 of the Applicant’s Arguments, the Applicant suggests unexpected results. The unexpected results are specifically directed to the method, and are not necessarily related to the apparatus, per se. Since there does not appear to be a claimed improvement to the device of Nicholls, any unexpected results are solely drawn to the method. As stated above, since the instant specification appears to use a commercially available device, wherein there is no description of modifications or improvements to the device, these results only apply to the method and not to the structural elements of the device.
On page 8 of the Applicant’s Arguments, the Applicant notes that there should not be a Non-Statutory Double Patenting Rejection on the claims, with respect to US Pat. 11,940,442. The cited restriction requirement was submitted for application 15/082,658, which was abandoned. The cited patent possesses application number 16/917,352, which was a Continuation of application ‘658, not a Divisional. Although the instant application is a Divisional of ‘352, the fact that there is a Continuation between the application with the Restriction Requirement and the child application means that the rejection is appropriate:
Note that a restriction requirement in an earlier-filed application does not carry over to claims of a continuation application in which the examiner does not reinstate or refer to the restriction requirement in the parent application. Reliance on a patent issued from such a continuation application to reject claims in a later-filed divisional application is not prohibited under 35 U.S.C. 121. Bristol-Myers Squibb Co. v. Pharmachemie BV, 361 F.3d 1343, 1348, 70 USPQ2d 1097, 1100 (Fed. Cir. 2004). See MPEP 804.01.
As such, the double patenting rejection is considered proper and will be maintained.
The Applicant has added new claims 21-30, these will be discussed in the rejections below. The 35 USC 112(a) rejection has been withdrawn. The 35 USC 102/103 rejections of the claims are maintained. No claim is allowed.
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 21, 23, 27, and 29 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.
Claims 21, 23, 24, 27, and 29 are considered indefinite because it is unclear what adaptations the Applicant has provided. See MPEP 2111.04. For example, although the cited prior art does not teach the claimed method of simultaneous administration, there is nothing about the structural components of the apparatus disclosed in Nicholls that would forbid a premixed solution. That is to say, the apparatus of Nicholls appears to already be adapted for this limitation. If a particular container or manifold system is required, this should be claimed, but barring structural limitations, it appears that the device of Nicholls could handle a premixed solution.
Similarly, for claims 23 and 24, the software that is built into the device of Nicholls appears as though it is already adapted for the claimed functionality, and as such, it is unclear what the Applicant is claiming.
Claim 27 provides for sensors adapted to sense oxygen and pH; however, since it appears as though Nicholls already provides for sensors that are adapted for these functions, it is unclear what adaptations the Applicant is claiming.
Claim 29 provides for a time interval adaptation, but it appears as though this adaptation could already be performed by the device of Nicholls. As such, it is unclear what adaptation the Applicant is claiming.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 16-30 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Nicholls, et al (Journal of Visualized Experiments, 46, e2511, 2010 [IDS Reference]). Nicholls provides for an apparatus that is used in a method of determining the metabolic potential of a cell. See “Abstract” section. Although Nicholls does not appear to explicitly describe elements of the claimed apparatus, method steps performed by Nicholls would suggest that these elements are necessary present on the apparatus of Nicholls. Based upon Nicholls’ disclosure, cells are seeded on a multiwell plate; although they are not described as being placed “on a stage,” any apparatus with optical sensors would likely be fitted with a stage. See page 2, “Seeding protocol” section. Nicholls describes a sensor, that is adapted to sense the same elements as those claimed. See page 2, “Loading sensor cartridge” section. Nicholls dispenses the test compounds through injection ports. See page 1, “Cell injection” section. Nicholls provides for an apparatus that is capable of measuring oxygen consumption rate (OCR) and extracellular acidification rate (ECAR). See page 4, Figure 3. Nicholls shows steps and data for determining the metabolic potential of a cell sample. See page 5, Figure 4. Nicholls does not explicitly state that the apparatus can simultaneously dispense reagents and simultaneously measure OCR/ECAR.
With respect to claims 16-20, based upon an analysis of the steps provided by Nicholls, and a general knowledge of computerized and mechanized testing apparatuses, it would appear that Nicholls describes an apparatus that is capable of all of the claimed limitations. That is to say, although Nicholls does not explicitly state any methods that involve simultaneously dispensing reagents and simultaneously measuring OCR/ECAR, these steps are performed with different injection ports and sensors, and as such, could easily be programmed to perform simultaneous injection and measurements. If it can be shown that Nicholls’ apparatus is incapable of these simultaneous steps, it would be obvious to the ordinary artisan to modify an apparatus to have highly customizable injection and analysis programming. The are no technological hurdles that must be overcome in order for Nicholls’ apparatus to be made in a manner to allow for simultaneous injection and sensing.
With respect to claim 21, Nicholls provides mitochondrial uncoupling agents and ATP synthase inhibitors in containers. If the ordinary artisan chooses to mix these agents, the containers appear to be adapted for this mixture; that is to say, there is nothing corrosive about the mixture that would affect the containers of Nicholls, and as such, they are adapted for this mixture (see the 35 USC 112(b) rejection above). There is nothing in these compounds to suggest that the container used by Nicholls could not handle the mixture, and as such, Nicholls’ device must have been adapted for this function.
With respect to claim 22, Nicholls describes a “cartridge” that appears consistent with that claimed. See page 2.
With respect to claims 23, 24, and 27, Nicholls provides for software that can calculate the claimed rates. See Figure 3. All of the cited data was acquired using oxygen and pH sensors.
With respect to claims 25 and 26, although Nicholls does use mammalian myoblasts, the ordinary artisan would understand that the apparatus of Nicholls could likely be adapted for any cell with a mitochondrion.
With respect to claim 28, since the apparatus claimed appears identical to that of Nicholls, and the claimed injection port does not appear to modify the commercially available device, would suggest that the claimed device is the same as that of Nicholls. This is underscored by the fact that the applied examples appear to teach the same, unmodified, device as that of Nicholls. See page 2, “Seeding Protocol” section.
With respect to claim 29, it appears as though Nicholls’ apparatus is capable of the claimed limitation.
With respect to claim 30, although Nicholls does teach 96-well plates, there is nothing non-obvious about using any number of plates for analysis, since reproducibility is the cornerstone of all scientific endeavors.
Double Patenting
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 16-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,940,442. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited patent provides for a method that would provide the ordinary artisan with enough information to anticipate the structure of the instantly claimed apparatus. Since there is no bar against Non-Statutory Double Patenting rejections that are applied to claims in different statutory categories this rejection is appropriate.
Conclusion
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 DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
