DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 May 2026 has been entered.
Response to Arguments
Applicant's arguments filed 29 May 2026 have been fully considered but they are not persuasive.
Rejections under 35 USC § 112(a)—written description
The remarks take the position that the amendment to claim 1 provides 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.”
Specifically, claim 1 as now amended requires “supplying an acetate modifier to the transport gas at a concentration of greater than about 1.5% volume/volume”, which is alleged to be higher than the concentration of acetate modifier in Wei. The remarks take the position that “by reciting supplying an acetate modifier to the transport gas at a concentration of greater than about 1.5% volume/volume, Claim 1 recites a specific limitation that is supported by Applicant's written description and enables the result of the claimed separation”.
This has not been found persuasive. While the prior art fails to disclose 1.5% volume/volume, the issue still remains as to how the separation and distinguishing occurs. As indicated in the applicant’s 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”. That is, by the remarks own admission, it is not merely the addition of the acetate modifier to an open ended range of concentration that allows for separation and distinguishing to occur, but by some calibration, operation, system design and/or combination thereof that allows for the separation to occur. This is further supported by paragraph [0081] of the originally filed specification which recites:
“the acetate modifier is introduced to the transport gas at greater than 1.5% volume/volume, for enhanced separation of species. In another embodiment, the acetate modifier is introduced to the transport gas at greater than about 2% volume/volume. In yet another embodiment, the acetate modifier is introduced to the transport gas at about 3% volume/volume.”
That is, the specification suggests the acetate modifier introduced to the transport gas at a greater than 1.5% volume/volume allows for “enhanced separation of species”, indicating that separation is possible at smaller concentrations. However, the instant specification is devoid of any suggestion of how the DMS functions to achieve the claimed result of separation and distinguishing, except to note that in the prior art such separation was not possible.
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”
Here, there is no disclosure as to how the result of separation and distinguishing is achieved. While the addition of a 1.5 v/v modifier to transport gas is disclosed to enhance separation, there is still no disclosure as to how the separation and distinguishing occurs from by the DMS, when the prior art clearly demonstrates that separation and distinguishing was not possible.
Additionally, the amendment raises a new grounds of rejection under 112(a) lack of written description discussed herein below.
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]). 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 requiring “at a concentration of greater than about 1.5% volume/volume”.
MPEP 2163.05 (III) recites "In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of "25%- 60%" and specific examples of "36%" and "50%." A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range, however a limitation to "between 35% and 60%" did meet the description requirement"
Here, the instant specification teaches at paragraph [0081] “the acetate modifier is introduced to the transport gas at greater than 1.5% volume/volume, for enhanced separation of species. In another embodiment, the acetate modifier is introduced to the transport gas at greater than about 2% volume/volume. In yet another embodiment, the acetate modifier is introduced to the transport gas at about 3% volume/volume.”
That is, the specification teaches a range of greater than 1.5% to about 3%, however the claim does not require an upper limit allowing the claim to read literally on embodiments outside of the greater than 1.5% to 3%. Therefore, the claim lacks written description for not requiring an upper limit as disclosed.
Claim 4 lacks written description for the same reasons as claim 1 above (i.e. no upper limit to the range of greater than 2% v/v)
Claims 2 and 4 lack written description by virtue of their dependencies on rejected claim 1.
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
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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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
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