DETAILED ACTION
Response to Arguments
Applicant's arguments filed 09 September 2026 have been fully considered but they are not persuasive.
Initially, it is noted that if evidence is filed with an affidavit or declaration under 35 CRF 1.132 to demonstrate possession and enabling disclosure before the effective filing date of the claimed invention, such evidence may be sufficient to overcome the outstanding rejections under 35 USC § 112(a) discussed herein below.
Rejections under 35 USC § 112(a)—written description—issue 1
Claim 1 has been amended to require an upper limit to the acetate modifier concentration. This is fully supported in the instant specification; therefore the rejection is withdrawn.
Rejections under 35 USC § 112(a)—written description—issue 2
The remarks take the position that the claimed result is achieved by the disclosure of paragraphs [0077] and [0079] teaching the application of a compensation voltage corresponding to a species to allow that species to transport through and exit from the DMS.
This has not been found persuasive as there is no disclosure of what CV for each species, nor how the CV is determined for each species. As discussed in the last office action, Bedford is evidence, in paragraph [0032], that:
“although DMS devices allow for the separation of structural isomers and isobaric compounds, the determination of optimal conditions for separating species can still be a challenge. For large panels of compounds, there is no guarantee that a single chemical modifier can be sufficient to separate all compounds of interest.”
It is noted that Bedford is by the inventors of the instant application and was filed after the earliest effective filing data of the instant claimed invention. Here, the instant remarks take the position that merely the recitation of applying a CoV to selectively transport each species through the DMS. However, the inventors in the later filed application admit that 1) determination of the optimal conditions for separating species can still be a challenge and 2) there is no guarantee that a single chemical modifier can be sufficient to separate all compounds of interest.
This suggests that operating the DMS is not in a manner conventional to the art, as evidenced by the later filed application indicating that setting the optimal conditions may be a challenge and separation is not a guarantee using a single modifier. Since, by the applicant’s own admission in a later filed patent, these conditions are challenging to determine and do not guarantee separation of all compounds of interest, it is clear that merely the sentence reciting that the species is selectively transported by selectively applying a corresponding voltage for that species to allow that species to transport through the exit from the DMS” is not sufficient to demonstrate possession of the “challenging” optimal conditions with “no guarantee” of separation using a single modifier. This taken in combination with the disclosure of the prior art that ethyl acetate is insufficient to generate baseline separate, indicates that the instant specification is insufficient to demonstrate possession of the claimed.
Rejections under 35 USC § 112(a)—enablement
The remarks take a similar position. This has not been found persuasive for the same reasons as discussed above. Moreover, it is noted that paragraph [0012] teaches methods for operating a DMS to enable separation of compounds. However, the only operation of the DMS disclosed is with respect to a prior art DMS operation discussed in paragraph [0002]. Clearly, since addition of acetic modifier to the transport gas was known to the prior not to separate and distinguish between the claimed isotopic and isobaric compounds and as indicated in the remarks of 25 February 2026 in discussion of the prior art Wei “A number of factors can affect DMS performance, including calibration and system design. Wei’s failure to establish the claimed separating and distinguishing of species could have been the result of calibration errors, operational errors, system design, or any combination thereof” one of ordinary skill in the art would recognize that merely adding acetate modifier to the transport gas of the DMS would not be sufficient to separate the claimed compounds, but instead there must be a particular calibration, operation, system design or combination thereof so as to enable one of ordinary skill in the art to make and use the distinguishing and separating.
Notably the specification is silent with respect to the particular manner of operating, calibrating, system design or combination to achieve the claimed result. Instead the specification teaches conventional DMS system ([0003], [0049]) or FAIMS or similar known DMS architectures ([0050]).
Additionally, a sentence discussing selective transport via Cov is not sufficient to demonstrate how to make and use the claimed invention as the Bedford reference (cited above) notes that separation is a challenge and there is no guarantee of separation using a single modifier.
The specification moreover expressly recites:
“the literature reports on successful separation of two or three interfering compounds specifically added to a prepared experimental sample, but don't provide a solution for separating and or discriminating between all potential interfering compounds within a complicated compound panel that might be present in a real world sample. The issue in this problem is that a successful method for real world sample analysis must reliably separate and discriminate between all of the panel compounds in order to return an analytically useful result. As a result DMS-MS analysis has been limited to specific cases where analysis does not require separation of interfering isobaric compounds such as opioids or benzos. Surprisingly, through extensive experimentation and analysis of the problem the inventors have identified a system and method for reliably separating all opioid and benzo compounds using DMS”
That is, the specification teaches the problem of separating and distinguishing has been a problem to the art and through “extensive experimentation and analysis the inventors have identified a system and method for reliably separating all opioid and benzo compounds using DMS.”
However, beyond the disclosure of “the inventors have discovered that an acetate modifier generally provides the best separation for interfering opioid and benzo molecules using a DMS system for gas phase separation.” There is no disclosure as to how the DMS is operated differently from the prior art to achieve the claimed result.
If the DMS is operated in the conventional manner, however the literature by applicant’s own admission was incapable of separating all opioid and benzo compounds even when adding an acetate modifier, it is unclear how the result is enabled. The remarks of 25 February suggest it requires some calibration, operation, system design, however, since the specification is devoid of any suggestion. This indicates that there is not enough information disclosed to make and use the invention. At best the results are shown (see figures 6a-6b), however except for the disclosure of the addition of an acetate modifier and enhancing separation by a particular concentration, there is not enough information disclosed to make and use the claimed method.
This is further evidenced by Bedford (US pgPub 2024/0282564) which teaches the efficacy of DMS separation can be enhanced by the addition of chemical modifiers ([0026]). Paragraph [0028] cites a reference by the instant inventors that discloses the utility of chemical modifiers to separate compounds. In particular Bedford recites in paragraph [0032]:
“As discussed above, although DMS devices allow for the separation of structural isomers and isobaric compounds, the determination of optimal conditions for separating species can still be a challenge. For large panels of compounds, there is no guarantee that a single chemical modifier can be sufficient to separate all compounds of interest.”
That is, it is clear that merely adding an single acetate modifier is not enough for the separation of structural isomer and isobaric compounds as evidenced by Wei, Hall and moreover as evidenced by Bedford (a later filed application which includes the same inventors) the optimal conditions for separating can still be a challenge and for large panels (such as claimed) one of ordinary skill in the art would recognize there is no guarantee that a single chemical modifier (as claimed) can be sufficient to separate all compounds of interest. In other words, how the DMS is operated to separate isomers and isobaric compounds is not predictable. The state of the prior art is that merely adding an acetate modifier is not sufficient. In a later filed application to the inventor Bedford, the applicant readily acknowledges the challenges with separating isomer and isobaric compounds. The applicant admits in the remarks of February that a particular calibration, system design and/or operation is required in order to achieve the disclosed separation. Taken together the specification fail to provide enough information to enable one of ordinary skill in the art to achieve the claimed invention.
Therefore, the remarks have been found unpersuasive and the rejection stands as reiterated herein below.
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 1-2 and 4-5 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.
Claim 1 lacks written description for “separating and distinguishing between multiple isotopic or isobaric opioid and multiple isotopic or isobaric benzodiazepine species within a sample selectively transporting the ions of each of the isotopic or isobaric opioid species and isotopic or isobaric benzodiazepine species through the DMS in the presence of the acetate modifier… the supplying of the acetate modifier allows separating and distinguishing between isotopic or isobaric opioid …and isotopic or isobaric benzodiazepine species”.
MPEP 2163.03 (V) recites:
“An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved”
Specifically, the claim is drafted as achieving the result of allowing separation and distinguishing between isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species achieved by the supply of an acetic modifier to a DMS. However, the specification is devoid of any discussion as to how the selective transport of ions in the presence of an acetate modifier is achieved via the DMS.
The specification merely suggests that supplying the acetate modifier will allow for separation and distinguishing between isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species (see [0062]-[0065] of the published application).
However, the specification is silent with respect to how the DMS is used or operated so as to achieve separation via the DMS. As evidenced by the instant specification and admitted in the applicant’s reply Wei is unable to separate isotopic or isobaric opioids with a DMS in the presence of acetate modifier. Moreover, Hall teaches on page 127 that “ethyl acetate modifier data shows no separation of the four benzodiazepines with an applied voltage of 1500 V”. Moreover, as recognized by the inventors in the later filed Bedford (US pgPub 2024/0282564) [0032]:
“As discussed above, although DMS devices allow for the separation of structural isomers and isobaric compounds, the determination of optimal conditions for separating species can still be a challenge. For large panels of compounds, there is no guarantee that a single chemical modifier can be sufficient to separate all compounds of interest.”
In other words, prior art suggests methods of operating the DMS, however in those methods in the presence of an ethyl acetate modifier either opioids or benzodiazepines were unable to be separated. This suggests that merely adding acetate modifier to a DMS is not sufficient to achieve the claimed result of separation and distinguishing between isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species. Therefore, there is no disclosed method of operating the DMS such that in the presence an acetate modifier allows the result of the claimed separation. The functionally claimed method cannot extend to all functioning of the DMS in the presence of an acetate modifier to achieve the claimed result when evidence is clearly shown that functioning of the DMS as suggested in either Wei or Hall or evidence by the applicant’s own later filed application does not allow for the separation to occur.
Therefore claim 1 fails to meet the written description requirement under 35 USC § 112(a).
Claims 2 and 4-5 lack written description by virtue of their dependencies on rejected claim 1.
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 1-2 and 4-5 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 lacks enabling disclosure for “separating and distinguishing between multiple isotopic or isobaric opioid and multiple isotopic or isobaric benzodiazepine species within a sample selectively transporting the ions of each of the isotopic or isobaric opioid species and isotopic or isobaric benzodiazepine species through the DMS in the presence of the acetate modifier… the supplying of the acetate modifier allows separating and distinguishing between isotopic or isobaric opioid …and isotopic or isobaric benzodiazepine species”
Specifically, the claim is drafted as achieving the result of allowing separation and distinguishing between isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species achieved by the supply of an acetic modifier. However, the specification is devoid of any discussion as to how the selective transport of ions in the presence of an acetate modifier is achieved via the DMS.
As discussed above, the state of the prior art in Wei or Hall disclose that supplying of the acetate modifier does not allow for separating and distinguishing between isotopic or isobaric opioid …and isotopic or isobaric benzodiazepine species.
Here, the breath of the claims covers any operation of the DMS in the presence of the acetate modifier at a concentration higher than 1.5%, however the specification is silent with respect to the operation of the DMS to achieve the claimed result. The state of the prior art, as evidenced by Wei and Hall discussed above, does not allow for separation and distinguishing between isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species in the presence of ethyl acetate. By applicant’s own admission “surprisingly, all the isotopic or isobaric benzodiazepine species and opioid species can be separated using a differential mobility spectrometer” (se agenda mailed 18 February 2026). Therefore, at the effective filing date of the claimed invention, adding ethyl acetate to a DMS would not predictably result in separation of isotopic or isobaric benzodiazepine and opioid species. Since there are specific methods in the prior art of operating the DMS that do not allow for separation and the specification is silent as to how the operation of the DMS in the presence of an acetate modifier to overcome the deficiencies of the prior art is not disclosed one of ordinary skill in the art would not be able to make and use the claimed invention.
Moreover, as admitted in the applicant’s reply, the way in which the DMS is calibrated or designed in Wei (and presumably Hall) results in the inability to separate and distinguish between isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species. However, the instant specification is notably silent with respect to how the DMS is operated such that the claimed result is achievable. Indeed, Hall even suggests a volume of the ethyl acetate to be 3% (see page 83, last full sentence teaches ethyl acetate has a significant effect on the mobility of BE 3.0 %).
Lastly, as discussed above, Bedford teaches “although DMS devices allow for the separation of structural isomers and isobaric compounds, the determination of optimal conditions for separating species can still be a challenge. For large panels of compounds, there is no guarantee that a single chemical modifier can be sufficient to separate all compounds of interest”. That is, by applicants own admission in a later filed application optimal conditions to separate isomers and isobaric compound is still a challenge and there is no guarantee that a single chemical modifier (i.e. the claimed “only modifier”) can be sufficient to separate all compounds of interest. This is additional evidence that the DMS could not predictable separate and distinguish the claimed without some undisclosed method of operating the DMS.
Therefore because the prior art suggests actual procedures for operating the DMS in the presence of ethyl acetate and in Wei there is no separation of opioids and in Hall there is no separation of benzodiazepines (page 127, last paragraph), there is not enough information to make and use the method of operating the DMS such that in the presence of ethyl acetate separation is achieved.
Claims 2 and 4-5 are non-enabled by virtue of their dependencies on rejected claim 1.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
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