DETAILED ACTION
Response to Amendment
The Amendment filed 28 August 2026 has been entered. Claims 1-29 remain pending in the application. Applicant’s Amendments to the Claims have overcome the Objections previously set forth in the Non-Final Office Action mailed 9 April 2026.
Terminal Disclaimer
The terminal disclaimers filed on 28 August 2026 and approved on 9 September 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of U.S. Patent Nos. 12,326,063 and 12,326,059 have been reviewed and are accepted. The terminal disclaimers have been recorded. Accordingly, the Double Patenting rejections over the same are rendered moot.
Allowable Subject Matter
Claims 1-29 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112 set forth in this Office action.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-29 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.
Claims 1-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
“an expandable metal member positioned about the housing, the expandable metal member comprising a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” and “positioning a reactive colloidal dispersion of colloid particles about a surface of the expandable metal member, thereby forming an expanded metal member having the colloid particles in interstitial spaces thereof,” wherein the metal is selected from the group consisting of magnesium and aluminum,
does not reasonably provide enablement for:
“an expandable metal member positioned about the housing, the expandable metal member comprising a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” and “positioning a reactive colloidal dispersion of colloid particles about a surface of the expandable metal member, thereby forming an expanded metal member having the colloid particles in interstitial spaces thereof,” wherein the metal is any/every metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Claims 1-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 1 has been Amended to recite “a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed.” Likewise, independent claims 11 recites “a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed.” Independent claim 11 further recites “positioning a reactive colloidal dispersion of colloid particles about a surface of the expandable metal member, thereby forming an expanded metal member having the colloid particles in interstitial spaces thereof.”
Upon consultation with the Specification, the Office observes that Applicant discloses “The hydrolysis of the expandable metal can create a metal hydroxide. The formative properties of alkaline earth metals (Mg - Magnesium, Ca - Calcium, etc.) and transition metals (Zn - Zinc, Al - Aluminum, etc.) under hydrolysis reactions demonstrate structural characteristics that are favorable for use with the present disclosure. Hydration results in an increase in size from the hydration reaction and results in a metal hydroxide that can precipitate from the fluid” ([0031]); “It should be noted that the starting expandable metal, unless otherwise indicated, is not a metal oxide (e.g., an insulator)” ([0032]); and further “The hydration reactions for magnesium is:
Mg + 2H2O → Mg(OH)2 + H2,
where Mg(OH)2 is also known as brucite. Another hydration reaction uses aluminum hydrolysis. The reaction forms a material known as Gibbsite, bayerite, boehmite, aluminum oxide, and norstrandite, depending on form. The possible hydration reactions for aluminum are:
Al + 3H2O → Al(OH)3 + 3/2 H2.
Al + 2H2O → AlO(OH) + 3/2 H2
Al + 3/2 H2O → ½ Al2O3 + 3/2 H2
Magnesium hydroxide is considered to be relatively insoluble in water. Aluminum hydroxide can be considered an amphoteric hydroxide, which has solubility in strong acids or in strong bases. Alkaline earth metals (e.g., Mg, Ca, etc.) work well for the expandable metal, but transition metals (Al, etc.) also work well for the expandable metal” ([0033]). However, Applicant does not describe or propose the hydration reactions for any of the other metals, nor does Applicant specify which other metals would expand under hydrolysis and under which mechanisms such metals would expand.
First, while there is a presumption that an adequate Written Description of the claimed invention is present in the Specification as filed, a question as to whether a Specification provides an adequate Written Description may arise in the context of an original claim. 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 or (2) a broad Genus claim is presented but the disclosure only describes a narrow Species with no evidence that the Genus is contemplated. See MPEP 2163.03 Typical Circumstances Where Adequate Written Description Issue Arises.
Also, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice…, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus... A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." See MPEP 2163.
In this case, (2) a broad Genus claim is presented (broadly encompassing all metals “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” including alkali metals, alkaline earth metals, and transition metals, i.e., Li, Na, K, Rb, Cs, Fr, Be, Mg, Ca, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Tc, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Au, Rg, Zn, Cd, Hg, Cn, Al, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, Lv) but the disclosure only describes a narrow Species (specifically, Mg and Al) with no evidence that the Genus is contemplated. For example, it is unclear under what conditions and how Ca expands in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed. Similarly, it is unclear under what conditions and how Au expands in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed. Similarly, it is unclear under what conditions and how Tc expands in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed. Similarly, it is unclear under what conditions and how Li, Na, K, Rb, Cs, Fr, Be, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Rg, Zn, Cd, Hg, Cn, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, or Lv expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed, especially how to do so for thereby forming an expanded metal member having the colloid particles in interstitial spaces thereof.
Furthermore, Applicant has not satisfactorily disclosed a “representative number of species” because the disclosure does not adequately reflect the structural diversity of the claimed genus. For example, although Applicant points to various metals, “metals” is not a sufficient description because the metals are well-known to have significant structural diversity e.g. in their electron configurations/orbitals, the differences of which result in highly-diverse reaction chemistries. Also, Applicant has only disclosed hydration reactions for Mg and Al ([0033]), but even these two examples are disclosed by Applicant to have distinct hydration reaction chemistries. Accordingly, Applicant has not adequately demonstrated possession of all of the claimed Species for “a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” especially how to do so for thereby forming an expanded metal hydroxide member having the colloid particles in interstitial spaces thereof.
Accordingly, the claims lack an adequate Written Description for their full scopes.
Second, based on the foregoing, per In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), the following Undue Experimentation factors support a determination that the disclosure satisfies the Enablement requirement for the Full claim Scope:
(C) The state of the prior art – because there appears to be Prior Art directed to expanding aluminum (e.g., WO 2013/033531, cited by Applicant);
However, the following Undue Experimentation factors do not support a determination that the disclosure satisfies the Enablement requirement for the Full claim Scope:
(A) The breadth of the claims – because the claims appear to broadly encompass all metals “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” including alkali metals, alkaline earth metals, and transition metals, i.e., Li, Na, K, Rb, Cs, Fr, Be, Mg, Ca, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Tc, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Au, Rg, Zn, Cd, Hg, Cn, Al, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, and Lv, but Applicant has only described how Mg and Al would be configured to expand in response to hydrolysis via specifically described means/mechanisms;
(B) The nature of the invention – because Applicant has disclosed that the metals may expand via different chemical mechanisms (e.g., compare Mg vs. Al in [0033]) and the chemistries appear to not necessarily apply across multiple chemicals;
(D) The level of one of ordinary skill – because oilfield artisans are medium-skilled and may select suitable amounts of given materials from preset lists but do not themselves assay chemicals to ascertain which chemicals may or may not be operable in the first place;
(E) The level of predictability in the art – because the chemical arts are relatively unpredictable, and the reaction by one metal would not reasonably predict reaction by another metal;
(F) The amount of direction provided by the inventor – because Applicant has not actually provided any guidance on what conditions or what reaction mechanisms would be appropriate for use of any of Li, Na, K, Rb, Cs, Fr, Be, Ca, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Tc, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Au, Rg, Zn, Cd, Hg, Cn, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, and Lv;
(G) The existence of working examples – because Applicant has not actually disclosed or described any working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure – because the quantity of experimentation needed to test which of the other metals are expandable in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed and under what conditions and via which reaction mechanisms appears to require at least testing each of the 89 metals which have not had reaction mechanisms described but which are claimed, vs. the 2 which have been described and which are claimed.
That is, one of the Wands factors support Enablement, while seven factors do not support Enablement, five of which relate directly to the current claim scope (A/B/D/F/H).
Accordingly, there also exists a Scope of Enablement deficiency for the current claims.
Third, based on the foregoing, it is unclear which metals are “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” i.e. via what conditions and mechanisms. For example, it is unclear under what conditions and how Ca would be “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” or not. Similarly, it is unclear under what conditions and how Au would be “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” or not. Similarly, it is unclear under what conditions and how Tc would be “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” or not. Similarly, it is unclear under what conditions and how Li, Na, K, Rb, Cs, Fr, Be, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Rg, Zn, Cd, Hg, Cn, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, or Lv would be “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” or not. Applicant has not adequately described the invention in a manner that would put the public on notice of which metal(s) under what condition(s) would be “a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” or not.
Accordingly, the claim scopes are also rendered Indefinite.
The dependent claims are rejected by dependency, also failing to limit the claims to the Described and Enabled scope in a Definite manner.
For examination purposes, claims will be read as though requiring the described and enabled Mg or Al embodiments as below. It is possible that Applicant has implicitly described additional embodiments based on what is known in the art at the time of filing (e.g., Ca - calcium), but Applicant must particularly point out and explain for each additional embodiment i) how each species has been sufficiently described such that one of ordinary skill in the art would recognize that the inventor was in possession of each species and ii) that those of ordinary skill are sufficiently enabled to practice each species. Mere generic statements referring to the disclosure are not sufficient to overcome these rejections. If Applicant alleges that all metals are “a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” Applicant must make a clear statement on the record of this to overcome the Definiteness rejection. However, such a statement would not be sufficient to overcome the Written Description and Scope of Enablement rejections, which require additional showings as above.
Applicant should also note that the suggestions below for the 112 Rejections would appear to make the claims identical to the 12,326,059 claims, and statutory Double Patenting over identical claims cannot be overcome by a Terminal Disclaimer. Accordingly, Applicant should additionally consider other changes to distinguish the current claims from 12,326,059 claims.
“1. (Currently Amended) A well system, comprising:
a wellbore positioned within a subterranean formation;
a downhole tool positioned within the wellbore, the downhole tool including:
a housing; and
an expandable metal member positioned about the housing, the expandable metal member comprising a metal configured to expand in response to hydrolysis, wherein the metal is selected from the group consisting of magnesium and aluminum; and
a reactive colloidal dispersion of colloid particles surrounding a surface of the expandable metal member.”
“11. (Currently Amended) A method, comprising:
positioning a downhole tool within a wellbore of a subterranean formation, the downhole tool including:
a housing; and
an expandable metal member positioned about the housing, the expandable metal member comprising a metal configured to expand in response to hydrolysis, wherein the metal is selected from the group consisting of magnesium and aluminum; and
positioning a reactive colloidal dispersion of colloid particles about a surface of the expandable metal member, thereby forming an expanded metal member having the colloid particles in interstitial spaces thereof.”
Response to Arguments
Applicant's arguments filed 28 August 2026 with respect to claims rejected under 35 USC § 112 (for Written Description, Scope of Enablement, and Definiteness) have been fully considered but they are not persuasive.
In Applicant’s arguments for 112(a) Written Description, Applicant points to the new language, stating “The Office Action asserts that the claims encompass every possible metal that might theoretically expand in response to hydrolysis while the Specification allegedly provides support only for magnesium and aluminum embodiments. However, the claims no longer present the scope characterized by the Office. As amended, independent Claims 1 and 15 recite an expandable metal member comprising a metal configured to undergo hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed. Independent Claim 29 recites the same hydrolysis and greater-volume relationship and further requires forming an expanded metal hydroxide member having the colloid particles in interstitial spaces thereof” and “The Specification expressly describes this very expansion mechanism. … The amended claims define the claimed class by the common chemical and volumetric characteristic disclosed as producing expansion, rather than merely by the label "metal." The Specification identifies multiple representative species exhibiting that characteristic and explains the relationship between hydrolysis, formation of a metal hydroxide, and increased volume “ (p.8-9).
However, first, Applicant should note that the Amended claims face the same fundamental deficiency: the claims encompass every possible metal that might theoretically expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed, while the Specification only describes this for magnesium and aluminum embodiments. The new claim language does not actually change the structure of the possible metals, only the functions of the possible metals.
Second, although Applicant states “The Specification further explains that the resulting metal hydroxide occupies a greater volume than the starting metal and provides specific examples demonstrating such volumetric expansion. For example, magnesium hydroxide occupies approximately 85% greater volume than magnesium, calcium hydroxide occupies approximately 32% greater volume than calcium, and aluminum hydroxide occupies approximately 160% greater volume than aluminum” (p.9), this statement does not appear to be described in the originally-filed Specification.
Applicant is reminded that, as in MPEP 2145, rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984), or otherwise presented during prosecution. See, e.g., MPEP §§ 714 to 716 et seq. However, arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
In this case, this rebuttal evidence i) has not been presented in the specification; nor ii) is not presented by way of affidavit or declaration under 37 CFR 1.132. Rather, this appears to be mere arguments presented by applicant which cannot take the place of factually supported objective evidence. Accordingly, this rebuttal evidence cannot be considered for rebutting the Office’s stance.
Furthermore, Applicant should note that even if this rebuttal evidence were considered, it would appear to only apply to the magnesium, calcium, and aluminum embodiments. However, as set forth previously and above, the claims broadly encompass alkali metals, alkaline earth metals, and transition metals, i.e., Li, Na, K, Rb, Cs, Fr, Be, Mg, Ca, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Tc, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Au, Rg, Zn, Cd, Hg, Cn, Al, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, Lv. This limited rebuttal evidence could not apply to any of these other possible metals because Applicant has pointed to no common structural characteristics which would link the rebuttal evidence for Mg, Ca, and Al to these other metals.
Third, Applicant states “The amended claims define the claimed class by the common chemical and volumetric characteristic disclosed as producing expansion, rather than merely by the label "metal." The Specification identifies multiple representative species exhibiting that characteristic and explains the relationship between hydrolysis, formation of a metal hydroxide, and increased volume. The amended claims therefore do not extend indiscriminately to all metals. Rather, they encompass the disclosed class of metals capable of undergoing the claimed hydrolysis reaction to produce a metal hydroxide having the recited greater-volume relationship” (p.9).
However, Applicant is reminded that, as in MPEP 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)
In this case, Applicant merely points to “the common chemical and volumetric characteristic,” but the characteristics pointed to by Applicant are not “disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.” For example, there is no common structure or other physical and/or chemical properties, because “metals configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” as described by Applicant do not necessarily share common structures or other physical and/or chemical properties, metals being well-known to have significant structural diversity e.g. in their electron configurations/orbitals, the differences of which result in highly-diverse reaction chemistries. Furthermore, Applicant did not describe functional characteristics coupled with a known or disclosed correlation between function and structure, because Applicant has only disclosed hydration reactions for Mg and Al ([0033]), but even these two examples are disclosed by Applicant to have distinct hydration reaction chemistries.
Accordingly, these arguments are not persuasive.
In Applicant’s arguments for 112(a) Scope of Enablement, Applicant states “The claims do not require a skilled artisan to make every metal in the periodic table expand. A metal falls within the claims only when it undergoes the recited hydrolysis reaction and forms a metal hydroxide having the claimed greater-volume relationship. The Specification teaches that mechanism, identifies representative metals and metal classes, and provides specific hydrolysis reactions and volumetric examples. The breadth and experimentation concerns premised upon treating every metal as an operative embodiment therefore no longer correspond to the scope of the amended claims” (p.9).
However, as set forth previously and above, the only way that the Specification would teach the mechanism, identify representative metals and metal classes, and provide specific hydrolysis reactions and volumetric examples for the entire class of “metals configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” would be if the mechanisms disclosed for Mg and Al (Specification [0033]) are understood to be further applicable to all metals such as alkali metals, alkaline earth metals, and transition metals, i.e., Li, Na, K, Rb, Cs, Fr, Be, Mg, Ca, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Tc, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Au, Rg, Zn, Cd, Hg, Cn, Al, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, Lv. Or, if the limited guidance provided by Applicant for Mg and Al would lead one of ordinary skill to ascertain which of the other metals of Li, Na, K, Rb, Cs, Fr, Be, Mg, Ca, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Tc, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Au, Rg, Zn, Cd, Hg, Cn, Al, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, Lv fall within the class set forth by Applicant. This is simply not a reasonable amount of guidance for the potential members of the claimed genus, without requiring undue experimentation to ascertain which of the other metals are capable of being configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed.
Furthermore, Applicant has not actually specifically rebutted any of the Wands factors analyzed by the Office.
Accordingly, this argument cannot be persuasive.
In Applicant’s arguments for 112(b) Definiteness, Applicant states “These amendments provide an objective structural and chemical boundary for the claimed metals. A person of ordinary skill in the art would readily understand whether a particular metal falls within the claim scope by determining whether, under hydrolysis, the metal forms a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed. The Specification provides multiple examples of this exact phenomenon and explains the underlying chemistry in detail” (p.10).
However, this mere generic statement referring to the disclosure fails to address the deficiency set forth by the Office. Fundamentally, Applicant has not provided sufficient guidance to put the public on notice of which metals are “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” vs. which metals are not “configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” except for the described Mg and Al embodiments ([0033]). If the public used a tool comprising gold (Au), is this “a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed” or not? What about Li, Na, K, Rb, Cs, Fr, Be, Mg, Ca, Sr, Ba, Ra, Sc, Y, La, Ac, Ce, Th, Pr, Pa, Nd, U, Pm, Np, Sm, Pu, Eu, Am, Gd, Cm, Tb, Bk, Dy, Cf, Ho, Es, Er, Fm, Tm, Md, Yb, No, Lu, Lr, Ti, Zr, Hf, Rf, V, Nb, Ta, Db, Cr, Mo, W, Sg, Mn, Tc, Re, Bh, Fe, Ru, Os, Hs, Co, Rh, Ir, Mt, Ni, Pd, Pt, Ds, Cu, Ag, Au, Rg, Zn, Cd, Hg, Cn, Al, Ga, In, Tl, Nh, Sn, Pb, Fl, Bi, Mc, or Lv?
Accordingly, this argument cannot be persuasive.
Nevertheless, Applicant may remedy the 112 Rejections by incorporating into the claims the specific metal structures (e.g., Mg, Al, etc.) which perform the claimed function.
As previously and above, it is possible that Applicant has implicitly described additional embodiments based on what is known in the art at the time of filing (e.g., Ca - calcium), but Applicant must particularly point out and explain for each additional embodiment i) how each species has been sufficiently described such that one of ordinary skill in the art would recognize that the inventor was in possession of each species and ii) that those of ordinary skill are sufficiently enabled to practice each species. Mere generic statements referring to the disclosure are not sufficient to overcome these rejections. If Applicant alleges that all metals are “a metal configured to expand in response to hydrolysis when contacted by a reactive fluid to form a metal hydroxide having a greater volume than the metal from which the metal hydroxide is formed,” Applicant must make a clear statement on the record of this to overcome the Definiteness rejection. However, such a statement would not be sufficient to overcome the Written Description and Scope of Enablement rejections, which require additional showings as above.
Applicant should also note that the suggestions above for the 112 Rejections would appear to make the claims identical to the 12,326,059 claims, and statutory Double Patenting over identical claims cannot be overcome by a Terminal Disclaimer. Accordingly, Applicant should additionally consider other changes to distinguish the current claims from 12,326,059 claims.
As always, Applicant may consider contacting the Examiner for an Interview or the like, in the case further explanation or guidance is desired.
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 ANDREW SUE-AKO whose telephone number is (571)272-9455. The examiner can normally be reached M-F 9AM-5PM EST.
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/ANDREW SUE-AKO/Primary Examiner, Art Unit 3674
