DETAILED ACTION
Response to Arguments
Applicant's arguments filed 25 February 2016 have been fully considered but they are not persuasive.
Rejections under 35 USC § 112(a): written description
Page 6 of the remarks have been found persuasive. The rejection is withdrawn. However, the amendment raises new issues discussed herein below.
Rejections under 35 USC § 112(a): enablement
Initially, it is noted the issue here is the prior art operates the DMS in the presence of an acetate modifier and results in the inability to separate opioid and benzodiazepine species. However, the specification is silent with respect to how the DMS is operated such that separation may be achieved (see detailed discussion in the rejection herein below).
Page 8 of the remarks take the position that Wei’s inability to separate the claimed groups of species using an acetate chemical modifier is not dispositive regarding enablement of the claimed features. Specifically suggesting that a number of factors affect DMS performance, including calibration and system design and that 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 which does not suggest that applicant’s disclosure is insufficient to enable one of ordinary skill in the art to practice the claimed method without undue experimentation.
This has not been found persuasive. MPEP 2164.05 recites:
“To overcome a prima facie case of lack of enablement, applicant must present argument and/or evidence that the disclosure would have enabled one of ordinary skill in the art to make and use the claimed invention at the time of filing….Such a showing also must be commensurate with the scope of the claimed invention, i.e., must reasonably enable the full scope of the claimed invention. See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021) (The court found that undue experimentation was required to enable the full scope of the claims where there was ample evidence that relevant artisans would not know how to perform the claimed invention for more than a narrow range of the claimed scope of invention. Moreover, there was no evidence of actual reduction to practice to support patentee’s rebuttal of the lack of enablement determination)” (emphasis added).
Here, the full scope of the claimed invention covers the method Wei, however as readily admitted by the remarks, Wei is unable to separate the claimed groups. That is, the claims have not been amended to distinguish the claimed method from that of a method taught by Wei that is evidence that the full scope of the claimed invention is not enabled. There is no claimed requirement for a specific calibration, operational configuration, system design that would distinguish the claimed method from that of Wei, therefore the claims are not fully enabled. As admitted in the interview agenda of 02/18/2026, “The present application teaches that, surprisingly, all of the isotopic or isobaric benzodiazepine species and opioid species can be separated using a differential mobility spectrometer (DMS) with the addition of an acetate modifier. This runs against conventional wisdom as evidenced by the prior art where it presents figures that show multiple compounds are transmitted and there are no voltage settings where all of the isotopic or isobaric species of a same mass are transmitted separately.”
That is, in addition to the evidence provided by Wei, the state of the prior art was that separation is not possible, suggesting the separation was not predictable at the effective filing date of the claimed invention. Therefore, the scope of the subject matter covers separation that is non-enabled.
Moreover, as discussed below the specification is silent with respect to how the DMS is operated to achieve separation of the isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species. As clearly evidenced by Wei and admitted by the applicant the separation is only achievable via some configuration of the DMS that is not disclosed in the instant application. Indeed both Wei and Hall are evidence of operating a DMS in the presence of an acetate modifier results in no separation of isotopic or isobaric opioid and isotopic or isobaric benzodiazepine species
Rejections under 35 USC 112(b)
Claim 1 has been clarified to overcome the previous indefinite rejection, however the amendment raises new issues discussed herein below.
Rejections under 35 USC § 103
The remarks have been found persuasive. Specifically, since Lui only teaches separation between Codeine and hydrocodone, Lui fails to suggest additional separation of multiple species of benzodiazepine.
Hall does not suggest that an acetate that may separate benzodiazepine species (see page 127 of Hall which teaches “ethyl acetate modifier data shows no separation of the four benzodiazepines with an applied voltage of 1500 V”).
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 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”
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.
MPEP 2173.05 (g) recites:
“Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983)”
Here, 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”.
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 does not allow for the separation to occur.
Therefore claim 1 fails to meet the written description requirement under 35 USC § 112(a).
Claims 2-5 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 1-5 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.
MPEP 2173.05 (g) recites:
“Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983)”
Here, the breath of the claims covers any operation of the DMS in the presence of the acetate modifier to allow, 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 %).
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 2-5 are non-enabled by virtue of their dependencies on rejected claim 1.
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 1-5 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.
Claim 1 is vague and indefinite for reciting “wherein the acetate modifier is the only modifier introduced to the MS, and wherein the supplying the acetate modifier allows for selective separating and distinguishing between isotopic or isobaric opioid species…and isotopic or isobaric benzodiazepine species including the following groups”.
Specifically, it is not clear whether the claimed isotopic or isobaric opioid species…and isotopic or isobaric benzodiazepine species” are the multiple isotopic or isobaric opioid species and isotopic or isobaric benzodiazepine species within the sample defined in the preamble of claim 1 or if these are species that the method is capable of separating. That is, it is not clear whether all the claimed species (i)-(ix) are included in the claimed sample or if the method allows for separation of some combination of the isotopic or isobaric opioid species…and isotopic or isobaric benzodiazepine species included in the sample. No unambiguous determination can be made.
Claims 2-5 are vague and indefinite by virtue of their dependencies on rejected claim 1.
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 MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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, 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.
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.
/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881