DETAILED ACTION
Maintenance Fees
MPEP 2504 explains that, for maintenance fees due on or after January 16, 2018, separate maintenance fees must be paid in:
Each reissued patent in force on (i.e., issued before) the maintenance fee due date. This includes all reissued patents that replace the same original patent.
An original patent that is not surrendered because one or more applications for reissue of that original patent are still pending on the maintenance fee due date.
USPTO records show that the four-year maintenance fee has been timely filed and, thus, maintenance fee payments are up to date for original US Patent No. 10,892,153 B2, i.e., the patent for which reissue is sought.
Applicant Submission
This Office action is responsive to the preliminary amendments filed on January 11, 2023 and March 17, 2023.
Claims Subject to Examination
Patent claims 1-28 and new reissue claims 29-65 are subject to examination.
Claim Construction
During examination, the pending claims are normally interpreted according to the broadest reasonable interpretation standard (hereinafter, the “BRI standard”). That is, claims are given their broadest reasonable interpretation consistent with the specification, and limitations in the specification are not read into the claims. See MPEP 2111 et seq.
An exception to the BRI standard occurs when the applicant acts as their own lexicographer. For this exception to apply, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess. See MPEP 2111.01, subsection IV.
Another exception or special case occurs when a claim recites a means-plus-function limitation that must be interpreted in accordance with 35 USC 112 ¶ 6, or 35 USC 112(f). See MPEP 2181. According to the guidance provided by Williamson v. Citrix Online, LLC, 792 F.3d 1339 (Fed. Cir. 2015) (en banc), 35 USC 112 ¶ 6 applies when the claim term fails to recite (i) sufficiently definite structure, and/or (ii) sufficient structure for performing the claimed function.
The following claim terms/limitations are construed by the examiner to aid in reexamination:
Claim Limitation:
the gas source being at a substantially higher pressure than that of the evacuated ionization volume (claims 1, 13, 22, 29, 34, 40, 45, 51 and 58)
Examiner’s Construction:
a gas source at any and all possible pressures that are perceptibly and/or measurably higher than the pressure of an evacuated ionization volume
Examiner’s Explanation:
The specification uses the phrase “substantially higher pressure” but fails to define this phrase. The specification identifies one preferred embodiment in which the sample gas pressure is typically greater than 1E-4 Torr (or 0.0001 Torr), and the ionization volume pressure is typically less than 2E-5 Torr (or 0.00002 Torr). Thus, in this one preferred embodiment, the gas source pressure is five times the ionization volume pressure. However, the specification provides no basis for determining all of the pressure differentials included in the phrase “substantially higher pressure” and all of the pressure differentials excluded from this phrase. For example, it is unclear whether a pressure differential of 1.25 times is included or excluded, it is unclear whether a pressure differential of 1.5 times is included or excluded, it is unclear whether a pressure differential of 2 times is included or excluded, etc. Thus, the claim limitation must be construed broadly.
Claim Limitation:
there being no restricted-conductance ionization chamber restricting flow from the nozzle to the vacuum pump such that gas passing through the nozzle freely expands through an ionization region of the ionization volume (claims 1, 13, 22, 29 and 34)
Examiner’s Construction:
the absence of an ionization chamber having a restricted conductance, which if it was present would restrict flow of the gas from the nozzle to the vacuum pump, and which if it was present would prevent free expansion of the gas through an ionization region of the ionization volume
NOTE: Since the limitation is a negative limitation, it does not positively recite a requirement that the gas undergoes free expansion through an ionization region of the ionization volume.
Examiner’s Explanation:
The specification:
Describes a prior art closed ion source including an ionization chamber having restricted gas exit conductance with only small openings for entrance and exit of gases, electrons and ions.
States that such a restricted-conductance ionization chamber (of the prior art) holds the sample gas in a relatively closed volume at a pressure higher than the average pressure in the mass spectrometer system, such that the gas is not freely expanding.
Describes the inventive ion source as not having a restricted-conductance ionization chamber (like that of the prior art), and as allowing the sample gas to expand in an unrestricted manner.
Claim Limitation:
small diameter tube (claim 2)
Examiner’s Construction:
a tube of any and all possible diameters that are perceptibly and/or measurably smaller than a dimension of some other component of an associated device or system
Examiner’s Explanation:
The specification uses the phrase “small diameter tube” but fails to define this phrase. The specification does not identify any preferred embodiment, i.e., any specific diameter or any specific relative diameter. Thus, the specification provides no basis for determining all of the diameters included in the phrase “small diameter” and all of the diameters excluded from this phrase. Thus, the claim limitation must be construed broadly.
Claim Limitation:
an ionizer source configured to emit ionizers, the ionizers passing through the freely expanding gas in the ionization region to ionize at least a portion of the expanding gas (claims 29, 40 and 51)
Examiner’s Construction:
any and all possible devices that constitute an “ionizer source” and that are configured to emit “ionizers” that pass through a freely expanding gas in an ionization region to ionize at least a portion of the expanding gas
Examiner’s Explanation:
The specification does not use the term “ionizer source” or the term “ionizers”, and the specification provides no definition of these terms. What the specification does describe is (i) electron source that emits electrons through the expanding gas in the ionization region to ionize at least a portion of the expanding gas; and (ii) a preferred embodiment in which the electron source is a heated filament. The specification also includes a general statement that the electron source may be any suitable electron source for generating electrons, but a heated filament is the only embodiment identified in the specification.
The specification does not mention or provide support for a broad class of devices known as ionizer sources that are configured to emit ionizers. Instead, the specification only provides support for a more limited class of devices known as electron sources and configured to emit electrons.
The specification provides no basis for determining all of the possible devices/structures included in the term “ionizer source” or all of the possible devices/structures/particles included in the term “ionizers”. For example, it is unclear whether or not a laser constitutes an “ionizer source” as claimed, or whether the output of a laser constitute an “ionizer” as claimed. Thus, the claim limitation must be construed broadly.
Claim Limitation:
emitting ionizers, the ionizers passing through the freely expanding gas in the ionization region to ionize at least a portion of the expanding gas (claims 34, 45 and 58)
Examiner’s Construction:
any and all possible steps of emitting “ionizers”, using any and all possible devices that are capable of emitting “ionizers”, wherein the “ionizers” pass through a freely expanding gas in an ionization region to ionize at least a portion of the expanding gas
Examiner’s Explanation:
See the explanation above with respect to the “ionizer source” and “ionizers” required by claims 29, 40 and 51.
Claim Limitation:
gas passing through the nozzle freely expanding through an ionization region of the ionization volume (claims 40, 45 and 51); gas passing through the nozzle freely expands through an ionization region of the ionization volume (claim 58)
Examiner’s Construction:
an absence of structural elements in a primary path along which a gas flows from a nozzle through an ionization region such that the gas undergoes expansion through the ionization region in a manner that is unconstrained along the primary path
Examiner’s Explanation:
The specification:
Describes a prior art closed ion source including an ionization chamber having restricted gas exit conductance with only small openings for entrance and exit of gases, electrons and ions.
States that such a restricted-conductance ionization chamber (of the prior art) holds the sample gas in a relatively closed volume at a pressure higher than the average pressure in the mass spectrometer system, such that the gas is not freely expanding.
Describes the inventive ion source as not having a restricted-conductance ionization chamber (like that of the prior art), and as allowing the sample gas to expand in an unrestricted manner.
The specification uses the phrase “freely expands” and “freely expanding” but fails to provide a clear definition of these phrases. On the one hand, the specification states that the ionization region can be considered a volume where the electrons pass through the sample gas that is “freely expanding” into the ionization volume, “unconstrained by electrodes or other structures,” and from which the generated ions are directed into the mass filter. On the other hand, the specification describes four electrodes 120a-120d that are “located away from the primary path” of the expanding gas and at distances from the nozzle 110 to “limit direct contact” of the electrodes 120a-d with the expanding gas. Thus, it is clear that the electrodes 120a-120d at least partially define the boundary of the ionization region, can be in a non-primary path of the expanding gas, and are capable of indirect contact with the expanding gas. Accordingly, the phrases “freely expands” and “freely expanding” do not refer to gas expansion in a completely/absolutely unrestrained manner in every possible direction.
Original Disclosure – Definition
The instant application seeks reissue of US Patent No. 10,892,153 B2, which issued from US Application No. 16/713,713, which was a continuation of US Application No. 15/621,241 (now US Patent No. 10,541,122 B2). The “original disclosure” is the disclosure of grandparent Application No. 15/621,241 as filed on June 13, 2017.
Prohibition of New Matter
35 USC 132(a) prohibits any amendment that introduces new matter into the disclosure of the invention.
35 USC 251(a) prohibits the introduction of new matter into the application for reissue.
Objection to Amendment – New Matter
The amendments filed on January 11, 2023 and March 17, 2023 are objected to under 35 USC 132(a) and 35 USC 251(a) because they improperly introduce new matter for the reasons given below.
The first paragraph of the patent specification has been amended to refer to US Patent Nos. 10,892,153 B2 and 10,541,122 B2. The paragraph concludes with the statement “The entire teachings of the above application(s) are incorporated herein by reference. This constitutes new matter because the original disclosure did not incorporate by reference the entire “teachings” of US Patent Nos. 10,892,153 B2 and 10,541,122 B2. The broad term “teachings” includes every part of the newly cited patents and, thus, encompasses more than just the original disclosure.
New claims 29, 40 and 51 recite “an ionizer source configured to emit ionizers, the ionizers passing through the freely expanding gas in the ionization region to ionize at least a portion of the expanding gas”. As explained in the Claim Construction section above, this subject matter constitutes new matter because the specification does not mention or provide support for a broad class of devices known as ionizer sources that are configured to emit ionizers. Instead, the specification only provides support for a more limited class of devices known as electron sources and configured to emit electrons. Thus, the scope of the new claims exceeds the scope of the original disclosure.
New claims 34, 45 and 58 recite “emitting ionizers, the ionizers passing through the freely expanding gas in the ionization region to ionize at least a portion of the expanding gas”. As explained in the Claim Construction section above, this subject matter constitutes new matter because the specification does not mention or provide support for a broad step of emitting ionizers (using a broad class of devices capable of emitting ionizers). Instead, the specification only provides support for a more limited step of emitting electrons (using a more limited class of devices known as electron sources). Thus, the scope of the new claims exceeds the scope of the original disclosure.
For these reasons, applicant’s amendments introduce new matter. Applicant is required to cancel the new matter in response to this Office action.
Reissue Oath/Declaration
The Reissue Application Declaration By The Assignee (i.e., Form PTO/AIA /06) filed on January 11, 2023 is defective because it was not properly executed. Specifically, on the supplemental sheet, the assignee’s representative has signed the declaration in the form fields labeled “Inventor’s Signature”. It is improper for the assignee’s representative to sign on behalf of inventors in this manner.
The reissue declaration is also defective because it fails to specifically identify at least one error which can be properly relied upon to support the reissue application. See 37 CFR 1.175 and MPEP 1414-1414.01.
As required by 37 CFR 1.175(a), the reissue oath/declaration must specifically identify at least one error pursuant to 35 U.S.C. 251 being relied upon as the basis for reissue. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. It is not sufficient to merely state that applicant seeks to broaden or narrow the scope of a patent claim. Further, a statement in the reissue oath/declaration of “…failure to include a claim directed to…” and then reciting all the limitations of a newly added claim would not be considered a sufficient error statement because applicant has not pointed out what the other claims lacked that the newly added claim has, or vice versa.
In the present case, the reissue declaration states the patentee claimed less than they had the right to claim because patent claim 1 requires an electron source. As explained in GROUND 3 below, this does not constitute a proper error for reissue because elimination of the electron source does not comply with the original patent requirement.
Listing of Prior Art
The following is a listing of the prior art cited in this Office action together with the shorthand reference used for each document (listed alphabetically):
“Benson et al.”
US Patent No. 2,938,116
“Blessing et al. ‘122”
US Patent No. 10,541,122 B2
“Boesl et al.”
US Patent No. 4,433,241
“Davis”
US Patent No. 3,770,954
“Helm et al.”
H. Helm et al., “Electron-impact ionization of Ar2, ArKr, Kr2, KrXe, and Xe2”, Physical Review A, Vol. 19, No. 6, June 1979, the American Physical Society, pp. 2154-2160
“Hull et al.”
US Patent No. 4,016,421
“Kato”
JP Publication No. 2005-085512 A (with translation)
“Knof et al.”
US Patent No. 3,860,848
“Pokar et al.”
US Patent No. 4,039,828
“Tateishi et al.”
US Publication No. 2016/0247669 A1
“Tiernan et al.”
US Patent No. 3,553,452
“Ueno”
JP Publication No. 2005-259482 A (with translation)
Claim Rejections – 35 USC § 251
The following is a quotation of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
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(b) MULTIPLE REISSUED PATENTS.—The Director may issue several reissued patents for distinct and separate parts of the thing patented, upon demand of the applicant, and upon payment of the required fee for a reissue for each of such reissued patents.
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(c) APPLICABILITY OF THIS TITLE.—The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent or the application for the original patent was filed by the assignee of the entire interest.
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(d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS. No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent.
GROUND 1: Claims 1-65 are rejected under 35 U.S.C. 251 as being based upon a defective reissue oath/declaration. See 37 CFR 1.175. The nature of the defect(s) in the reissue oath/declaration is explained above.
GROUND 2: Claims 29-65 are rejected under 35 U.S.C. 251 as being based upon new matter added to the patent for which reissue is sought. The added material which is not supported by the prior patent is explained above. Dependent claims are included in this rejection because of their dependencies.
GROUND 3: Claims 29, 30, 32-35, 37-41, 43-46, 48-52, 54-59 and 61-65 are rejected under 35 U.S.C. 251 for failing to comply with the original patent requirement. See MPEP 1412.01.
As explained in MPEP 1412.01:
The reissue claims must be for the same invention as that disclosed as being the invention in the original patent, as required by 35 U.S.C. 251. The entire disclosure, not just the claim(s), is considered in determining what the patentee objectively intended as the invention. See In re Amos, 953 F.2d 613, 21 USPQ2d 1271 (Fed. Cir. 1991); and In re Rowand, 526 F.2d 558, 187 USPQ 487 (CCPA 1975).
The patentee’s “intent to claim” is analogous to the written description requirement of 35 USC 112(a). See In re Mead, 581 F.2d 251, 198 USPQ 412 (CCPA 1978). However, the original patent standard and the written description requirement are not the same. Where the written description requirement is based on what the skilled artisan would have understood was within the possession of the inventor, recent Federal Circuit case law indicates that the original patent requirement requires something more.
A claim submitted in reissue may be rejected under the original patent clause of 35 USC 251 if the original specification demonstrates, to one skilled in the art, an absence of disclosure sufficient to indicate that a patentee could have claimed the subject matter. The essential inquiry is whether one skilled in the art, reading the specification, would identify the subject matter of the new claims as invented and disclosed by the patentee. See In re Amos.
The original patent requirement is not satisfied when the patent only discloses one invention (e.g., a particular class of jet injectors), as evidenced by the clearly repetitive use of a descriptive term or classifier (e.g., jet injector) throughout the specification, but the reissue claims recite a broader/different invention (e.g., a generic injector encompassing a non-jet injector). See Antares Pharma Inc., v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014).
Where a new invention is sought by reissue, the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention. See Antares Pharma Inc., v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). Accordingly, claims drawn to an invention comprising a newly claimed combination of features, which were only disclosed in the original patent as suggested alternatives (and not as a single combination), or which were only disclosed as part of the original invention and not as an invention separate from the original invention, would not satisfy the original patent requirement. See Antares Pharma Inc.
When the written description and drawings fail to disclose that a feature required by the patent claims is an optional feature of the invention, omission of such feature from the reissue claims fails to satisfy the original patent requirement. See Forum US, Inc. v. Flow Valve, LLC, 926 F.3d 1346, 1352, 2019 USPQ2d 221227 (Fed. Cir. 2019).
As explained in the Claim Construction section above:
The specification does not use the term “ionizer source” or the term “ionizers”, and the specification provides no definition of these terms. What the specification does describe is (i) electron source that emits electrons through the expanding gas in the ionization region to ionize at least a portion of the expanding gas; and (ii) a preferred embodiment in which the electron source is a heated filament. The specification also includes a general statement that the electron source may be any suitable electron source for generating electrons, but a heated filament is the only embodiment identified in the specification.
The specification does not mention or provide support for a broad class of devices known as ionizer sources that are configured to emit ionizers. Instead, the specification only provides support for a more limited class of devices known as electron sources and configured to emit electrons.
As demonstrated above, the entirety of the specification indicates that the invention is specifically directed to an ion source (and method of using the same) comprising an electron source that emits electrons through the expanding gas in the ionization region to ionize at least a portion of the expanding gas.
Claims 29, 30, 32-35, 37-41, 43-46, 48-52, 54-59 and 61-65 fail to meet the original-patent requirement because:
These reissue claims are not directed to the same invention as that disclosed as being the invention in the original patent. Rather, the reissue claims are directed to an ion source and method of using the same comprising a broad class of devices known as ionizer sources that are configured to emit ionizers.
The patent only discloses one invention (e.g., a particular class/type of ion source comprising an electron source that emits electrons), as shown by the evidence identified above, but the reissue claims recite a broader/different invention (e.g., an ion source comprising a generic ionizer source that emits generic ionizers).
The patent’s disclosure does not clearly and unequivocally establish that the invention encompasses any class/type of ionizer source that emits any class/type of ionizers.
The written description and drawings fail to disclose that the electron source that emits electrons (as recited in the patent claims) is an optional feature of the invention. Thus, omission of such feature from the reissue claims fails to satisfy the original patent requirement.
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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.
GROUND 4: Claims 29-65 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement because these claims recite new matter. The added material which is not supported by the original disclosure is explained above. Dependent claims are included in this rejection because of their dependencies.
GROUND 5: Claims 29, 30, 32-35, 37-41, 43-46, 48-52, 54-59 and 61-65 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. These claims contain 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.
The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” Nevertheless, not everything necessary to practice the invention need be disclosed; all that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. With respect to the breadth of a claim, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In other words, the scope of the claims must be less than or equal to the scope of the enablement provided by the specification. See MPEP 2164.08.
As explained in the Claim Construction section above:
The specification does not use the term “ionizer source” or the term “ionizers”, and the specification provides no definition of these terms. What the specification does describe is (i) electron source that emits electrons through the expanding gas in the ionization region to ionize at least a portion of the expanding gas; and (ii) a preferred embodiment in which the electron source is a heated filament. The specification also includes a general statement that the electron source may be any suitable electron source for generating electrons, but a heated filament is the only embodiment identified in the specification.
The specification does not mention or provide support for a broad class of devices known as ionizer sources that are configured to emit ionizers. Instead, the specification only provides support for a more limited class of devices known as electron sources and configured to emit electrons.
Claims 29, 30, 32-35, 37-41, 43-46, 48-52, 54-59 and 61-65 are construed broadly to cover any and all possible devices that constitute an “ionizer source” and that are configured to emit “ionizers” that pass through a freely expanding gas in an ionization region to ionize at least a portion of the expanding gas. However, the original disclosure only describes (i) a preferred embodiment in which a heated filament serves as an electron source that emits electrons, and (ii) the possibility of using other electron sources though no such other electron sources are identified or described in detail. Further, the patent specification is silent as to the use of a broad class of devices known as ionizer sources that are configured to emit ionizers. Apart from the disclosure of an electron source, no other ionizer sources are identified in the disclosure or described in detail so as to enable the skilled artisan to make and/or use the claimed ion source including a broad class of devices known as ionizer sources that are configured to emit ionizers. Thus, the scope of the claims (encompassing any and all possible ionizer sources configured to emit any and all possible ionizers) is far greater than the scope of enablement provided by the specification (describing only one specific embodiment in which a heated filament serves as an electron source that emits electrons).
Concerning the Wands factors (see MPEP 2164.01(a)):
The scope of claims 29, 30, 32-35, 37-41, 43-46, 48-52, 54-59 and 61-65 is very broad because they cover any and all possible ionizer sources configured to emit any and all possible ionizers.
The nature of the invention is an ion source for producing ions to be used in a mass spectrometer.
The prior art considered by the examiner establishes that:
It was known in the art to produce ions to be used in a mass spectrometer using a variety of different ion sources, including those that produce ions by electron impact (EI); chemical ionization (CI); surface ionization/thermal ionization (SI/TI); and photoionization (PI).
Various ionization sources are employed to ionize the analytes because of the fact that various physicohemical ionizing methods must be used depending on the physicochemical behavior of the compound to be ionized.
In the EI method, a beam of electrons is directed into the gas-phase sample. Electrons collide with neutral sample molecules, producing ions of the sample molecule, or of fragments of the molecules.
In the CI method, a reagent gas is ionized by interaction with an electron beam. A sufficiently high reagent gas pressure can produce ion-molecule reactions between the reagent gas ions and reagent gas molecules. Some of these reaction products react with sample molecules to produce sample ions.
The SI/TI method creates ions when gaseous atoms or molecules interacting with a hot surface transfer an electron to or from the surface.
In the PI method, a high-energy photon, from an ultraviolet light or laser, interacts with a gaseous atom or molecule, transferring enough energy for it to lose an electron.
Some methods, which operate on liquid samples or solid samples, would not be considered suitable for the claimed ion source that produces ions from a gaseous sample.
The skilled artisan is familiar with prior art ion sources, including those discussed above. However, the skilled artisan would not be aware of any and all possible ionizer sources configured to emit any and all possible ionizers (including those not yet known in the art).
The level of predictability in the art is considered to be relatively low because each chemical element/compound to be analyzed by a mass spectrometer requires testing and evaluation of its physicochemical behavior in order to determine which method of producing ions is suitable for use therewith. This testing and evaluation is quite complex.
The amount of direction provided by the inventor is very limited in comparison to the scope of the claims. The original disclosure only describes (i) a preferred embodiment in which a heated filament serves as an electron source that emits electrons, and (ii) the possibility of using other electron sources though no such other electron sources are identified or described in detail. Further, the patent specification is silent as to the use of a broad class of devices known as ionizer sources that are configured to emit ionizers. Apart from the disclosure of an electron source, no other ionizer sources are identified in the disclosure or described in detail. In contrast, the claims broadly cover any and all possible ionizer sources configured to emit any and all possible ionizers. Thus, the scope of enablement provided to one skilled in the art by the disclosure is not commensurate with the scope of protection sought by the claims. Rather, the specification leaves the skilled artisan to develop his/her own solutions for achieving the any and all possible devices covered by the claims.
(G) Applicant’s specification does not provide evidence of the existence of working examples that are representative of the any and all possible ionizer sources configured to emit any and all possible ionizers covered by the claims.
(H) Due to the insufficiency of applicant’s disclosure, an undue amount of experimentation would be needed to make or use the full scope of the invention encompassed by the claims. For example, the skilled artisan would have to engage in extensive and complex experimentation to determine:
What devices, whether known or yet to be discovered, constitute “ionizer sources” that are configured to emit “ionizers”, including which of the plurality of known ion sources constitute “ionizer sources” that are configured to emit “ionizers”.
What devices, whether known or yet to be discovered, are capable of emitting “ionizers” that pass through a freely expanding gas in an ionization region to ionize at least a portion of the expanding gas, including which of the plurality of known ion sources are capable of performing this function.
What alternatives to the disclosed electron source (i.e., heated filament), whether known or yet to be discovered, would be suitable to serve as the claimed “ionizer sources” for emitting “ionizers” that pass through a freely expanding gas in an ionization region to ionize at least a portion of the expanding gas.
How alternative to the disclosed electron source (i.e., heated filament) would need to be structured, and how they would need to be incorporated into the structure of a mass spectrometer, in order to serve as the claimed “ionizer sources” that are configured to emit “ionizers”.
Thus, for claims 29, 30, 32-35, 37-41, 43-46, 48-52, 54-59 and 61-65, the specification does not reasonably provide enablement for the entire scope of the claimed invention.
GROUND 6: Claims 29, 30, 32-35, 37-41, 43-46, 48-52, 54-59 and 61-65 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
The written description requirement serves both to satisfy applicant’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the inventor(s) was in possession of the invention that is claimed. It is not enough that a skilled artisan could theoretically construct his/her own version of the claimed invention. Rather, applicant bears the burden of setting forth sufficient information to show that the inventor had possession of the claimed invention. Thus, the written description requirement requires applicant to go beyond a discussion of mere concepts and suggestions. It is not sufficient to merely outline desired results that the claimed invention is expected to achieve. Rather, the specification must explain how the invention is structured and how it functions in order to achieve the desired results. While subject matter that is conventional or well known in the art need not be described in detail, the specification must provide a complete description of each of the essential features recited in the claims which enable the claimed invention to achieve the desired results.
As explained in the Claim Construction section above:
The specification does not use the term “ionizer source” or the term “ionizers”, and the specification provides no definition of these terms. What the specification does describe is (i) electron source that emits electrons through the expanding gas in the ionization region to ionize at least a portion of the expanding gas; and (ii) a preferred embodiment in which the electron source is a heated filament. The specification also includes a general statement that the electron source may be any suitable electron source for generating electrons, but a heated filament is the only embodiment identified in the specification.
The specification does not mention or provide support for a broad class of devices known as ionizer sources that are configured to emit ionizers. Instead, the specification only provides support for a more limited class of devices known as electron sources and configured to emit electrons.
For the reasons explained above, the specification fails to provide an adequate written description to establish that the inventors were in possession of a generic “ionizer source” configured to emit “ionizers”. That is, the specification fails to describe a representative number of embodiments to establish possession of a broad class of devices known as ionizer sources that are configured to emit ionizers. Instead, only one specific embodiment is disclosed.
With respect to claims 12 and 21, the specification merely states that the voltages applied to the various electrodes may be independently controllable. While exemplary voltage values and/or ranges of values are mentioned, the specification is silent as to any control device or control system that carries out independent control of the voltages. Absent any explanation of the structure and function of the required controller, the specification fails to establish possession of the invention recited in claims 12 and 21.
Claim Rejections - 35 USC § 112(b)
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.
GROUND 7: Claims 1-65 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.
Claims 1, 29, 40 and 51 each recite “an evacuated ionization volume evacuated by a vacuum pump”, claim 13 recites “an evacuated ionization volume evacuated by the vacuum pump”, and claims 22, 34, 45 and 58 recite “evacuating an ionization volume with a vacuum pump”. By definition, such a “volume” has a defined and measurable amount of space. Further, such a volume is necessarily confined by some surrounding structure that defines the amount of space it possesses. However, applicant’s specification fails to (i) identify the defined and measurable amount of space possessed by the claimed volume, (ii) describe the surrounding structure that defines its amount of space, and (iii) explain how the vacuum pump interacts with the claimed volume and its surrounding structure to evacuate the claimed volume. Given this lack of supporting disclosure, it is impossible to ascertain with a reasonable degree of certainty what structurally-defined volumes are included in the scope of the claims, what structurally-defined volumes are excluded therefrom, what structural interrelationships between the claimed volume and the claimed pump are included in the scope of the claims, and what structural interrelationships (between volume and pump) are excluded therefrom. In addition, with respect to the specific pressures required by claims 40, 45, 57 and 65 and the relative pressures required by claims 51, 56, 58 and 64, it is impossible to ascertain with a reasonable degree of certainty what vacuum pump configurations are included in the scope of the claims (to produce the claimed pressures), and what are excluded therefrom.
Claims 1, 13, 22, 29, 34, 40, 45, 51 and 58 each recite “the gas source being at a substantially higher pressure than that of the evacuated ionization volume” As explained in the Claim Construction section above, the specification provides no basis for determining all of the pressure differentials included in the phrase “substantially higher pressure” and all of the pressure differentials excluded from this phrase. For example, it is unclear whether a pressure differential of 1.25 times is included or excluded, it is unclear whether a pressure differential of 1.5 times is included or excluded, it is unclear whether a pressure differential of 2 times is included or excluded, etc. Given this lack of supporting disclosure, it is impossible to ascertain the scope of the claims with a reasonable degree of certainty.
Claims 1, 13, 22, 29 and 34 recite “there being no restricted-conductance ionization chamber restricting flow from the nozzle to the vacuum pump such that gas passing through the nozzle freely expands through an ionization region of the ionization volume”. Claims 40, 45 and 51 recite “gas passing through the nozzle freely expanding through an ionization region of the ionization volume”. Claim 58 recites “gas passing through the nozzle freely expands through an ionization region of the ionization volume”. As explained in the Claim Construction section above, the specification uses the phrase “freely expands” and “freely expanding” but fails to provide a clear definition of these phrases. On the one hand, the specification states that the ionization region can be considered a volume where the electrons pass through the sample gas that is “freely expanding” into the ionization volume, “unconstrained by electrodes or other structures,” and from which the generated ions are directed into the mass filter. On the other hand, the specification describes four electrodes 120a-120d that are “located away from the primary path” of the expanding gas and at distances from the nozzle 110 to “limit direct contact” of the electrodes 120a-d with the expanding gas. Thus, it is clear that the electrodes 120a-120d at least partially define the boundary of the ionization region, can be in a non-primary path of the expanding gas, and are capable of indirect contact with the expanding gas. Accordingly, the phrases “freely expands” and “freely expanding” do not refer to gas expansion in a completely/absolutely unrestrained manner in every possible direction. Given this inconsistency and/or lack of clarity of supporting disclosure, it is impossible to ascertain the scope of the claims with a reasonable degree of certainty.
Claim 2 recites “a small diameter tube”. As explained in the Claim Construction section above, the specification uses the phrase “small diameter tube” but fails to define this phrase. The specification does not identify any preferred embodiment, i.e., any specific diameter or any specific relative diameter. Thus, the specification provides no basis for determining all of the diameters included in the phrase “small diameter” and all of the diameters excluded from this phrase. Given this lack of supporting disclosure, it is impossible to ascertain the scope of the claims with a reasonable degree of certainty.
In claims 8, 11, 17 and 20, the term “the surfaces of the first and second electrodes” (claim 8, ll. 3-4; claim 11, ll. 4-5; claim 17, ll. 3-4; claim 20, ll. 4-5) lacks proper antecedent basis.
With respect to claims 12 and 21, the specification merely states that the voltages applied to the various electrodes may be independently controllable. While exemplary voltage values and/or ranges of values are mentioned, the specification is silent as to any control device or control system that carries out independent control of the voltages. Absent any explanation of the structure and function of the required controller, it is impossible to ascertain the scope of the claims with a reasonable degree of certainty.
Claim 26 recites “wherein emitting electrons includes emitting electrons through an aperture of a second electrode on an opposite side of the ionization region”. This subject matter is indefinite because it fails to conform to the description of the invention in the specification. While the emitted electrons are described as traveling through a second electrode on an opposite side of the ionization region, such travel occurs after the electrons are emitted. It is not part of the step of emitting the electrons.
Claims 29, 40 and 51 recite “an ionizer source configured to emit ionizers, the ionizers passing through the freely expanding gas in the ionization region to ionize at least a portion of the expanding gas”. Claims 34, 45 and 58 recite “emitting ionizers, the ionizers passing through the freely expanding gas in the ionization region to ionize at least a portion of the expanding gas”. As explained in the Claim Construction section above, the specification provides no basis for determining all of the possible devices/structures included in the term “ionizer source” or all of the possible devices/structures/particles included in the term “ionizers”. For example, it is unclear whether or not a laser constitutes an “ionizer source” as claimed, or whether the output of a laser constitute an “ionizer” as claimed. Given this lack of supporting disclosure, it is impossible to ascertain the scope of the claims with a reasonable degree of certainty.
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).
GROUND 8: Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 (Blessing et al. ‘122) in view of Pokar et al. and Tateishi et al.
Claims 1-28 of the instant application recite essentially the same ion source as claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2. While some claim limitations are arranged differently in claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2, modifications involving mere rearrangement of claim limitations is considered to be obvious to one of ordinary skill in the art. Further, while claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 recite some limitations that are not found in claims 1-28 of the instant application, modifications involving the mere elimination of claimed features is also within the level of ordinary skill in the art.
Claims 1-28 of the instant application differ from claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 because claims 1-28 of the instant application require evacuation of an ionization volume by a vacuum pump whereas claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 do not include this requirement.
Pokar et al. and Tateishi et al. both teach evacuation of an ionization volume by a vacuum pump. See the explanation with respect to Pokar et al. and Tateishi et al. in the grounds of rejection that follow. From these teachings, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 to include evacuation of an ionization volume by a vacuum pump because it is well known that such evacuation facilitates the process of isolating desired sample molecules for interaction with the electrons generated by the electron source.
GROUND 9: Claims 40-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 (Blessing et al. ‘122) in view of Pokar et al. and Tateishi et al. and further in view of Knof et al., Pokar et al., Davis and Helm et al.
Claims 40-65 of the instant application differ from claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 because claims 40-65 of the instant application require specific pressures and relative pressures whereas claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 do not include this requirement.
Knof et al., Pokar et al., Davis and Helm et al. teach and/or render obvious the claimed pressures and relative pressures. See the explanation with respect to Knof et al., Pokar et al., Davis and Helm et al. in the grounds of rejection that follow. From these teachings, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claims 1-12, 15-23 and 25-31 of U.S. Patent No. 10,541,122 B2 to include the claimed pressures and relative pressures in order to facilitate the process of isolating desired sample molecules for interaction with the electrons generated by the electron source, and moving the sample and the generated ions through the ion source.
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