Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Written Description
Claims 11-12, 14-17, 57-64 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 11, lines 5-, recites “a solid film formed from a liquid matrix in which beads are suspended, the liquid matrix being liquid at room temperature and solidifying after application to a solid surface, wherein the solid film directly adheres the beads to the solid surface such that at least some of the beads remain adhered during an incubation step at a temperature greater than 60 degrees Centigrade, a liquid matrix comprising at least one material selected from the group consisting of soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, gamma globulin, glycogen, methyl cellulose, trehalose, chitosan, and alginate…”.
Claim 57, lines 4-7, recites “a solid film formed from a liquid matrix in which beads are suspended, the liquid matrix being liquid at room temperature and solidifying after application to a solid surface, wherein the solid film directly adheres the beads to the solid surface such that at least some of the beads remain adhered during an incubation step at a temperature greater than 60 degrees Centigrade, the liquid matrix comprising at least one material selected from the group consisting of soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, gamma globulin, glycogen, methyl cellulose, trehalose, chitosan, and alginate…”
Claim 58, lines 5, and 10-11 recites “the solid film is formed from a liquid matrix wherein the beads are suspended;…..wherein a portion of the beads remain adherent to the solid surface at a temperature of over 60 degrees centigrade.”
Claims 59, 61 and 63 each recite “wherein the liquid matrix includes soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, or gamma globulin” (emphasis added). [Examiner notes that while these claims recite specific proteins, these claim does not require any of the carbohydrates listed in the independent claim 11, 57, and 58. In other words, claims 11, 57, 58, 59, 61 and 63 do not require a soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, or gamma globulin, in addition to a carbohydrate listed in claim 11, since they do not recite for example, --wherein the liquid matrix includes a protein selected from….and a carbohydrate selected from…..--]
Claims 60, 62 and 64 recite “wherein the carbohydrate includes glycogen, methyl cellulose, trehalose, chitosan, or alginate.” (Emphasis added). [Examiner notes that claims 60, 62 and 64, while requiring specific the proteins recited in claims 49, 61 and 63, from which depend, respectively, nevertheless do not require any of the carbohydrates listed in the independent claims 11, 57, 58, 60, 62 and 64, since claims 60, 62 and 64 merely refer back to carbohydrates listed in independent claims 11, 57 and 58, respectively that are listed in the alternative to all the recited proteins and carbohydrates.]
Thus the above claims encompass requiring only one reagent (i.e., one of the recited proteins and carbohydrates), and any of their dependent claims likewise encompass requiring only one reagent.
While Applicant has described in the specification certain compositions (such as the combination of a protein and carbohydrate disclosed in paragraph 0124) such that these compositions meet the written description requirement, the scope of Applicants claims are much broader and do not meet the written description requirement for compositions not disclosed by Applicants. The compositions disclosed in paragraphs 0031 and 0124, for example, includes the category of a carbohydrate and a protein, and Applicant has given specific examples of a carbohydrate and a protein.
Examiner emphasizes that it is the scope of Applicant’s claims that fail to meet the written description requirement.
Applicant’s specification in the US Pre-Grant Publication 20160274006 discloses the following, which supports that the liquid matrix comprises at least one of the disclosed protein and one of the disclosed a carbohydrate.
“The liquid matrix may comprise several different types of compounds mixed together, including a carbohydrate, protein, solubilized collagen, a non-ionic detergent, or an anti-microbial preservative, or combinations thereof. Examples of suitable carbohydrates can include glycogen, methyl cellulose, or trehalose. Examples of proteins can include keyhole limpet hemocyanin (KLH), bacterial glutathione-S-transferase, or bovine gamma globulin. Examples of collagen can include solubilized type I or type IV collagen. An example of a suitable non-ionic detergent can be beta-octyl glucopyranoside.” Para. 0014 (emphasis added).
“In another aspect, a solution can include a carbohydrate, a protein, and solubilized collagen wherein the solution solidifies after application to a solid surface so that particles suspended in the solution are adhered to the solid surface.” Para. 0030 (emphasis added).
“In certain embodiments, the solution can be characterized by the capacity to retain at least 25% of the particles after solidification and then immersion in a liquid heated to 60 degrees Centigrade or higher. In certain embodiments, the carbohydrate can be glycogen, methyl cellulose, trehalose, chitosan, or an alginate. In certain embodiments, the protein can be keyhole limpet hemocyanin, glutathione-S-transferase, or gamma globulin. In certain embodiments, the collagen can be solubilized type 1 or solubilized type 4 collagen. In certain embodiments, the solution can include a non-ionic detergent. In certain embodiments, the solution can be characterized by the capacity to retain at least 25% of the particles after solidification and then immersion in an organic solvent.” Para. 0031 (emphasis added).
“The liquid matrix solution optimally comprises five distinct components: a carbohydrate, protein, solubilized collagen, a non-ionic detergent, and an anti-microbial preservative. For all of these components, there is a range of suitable concentrations. An exemplary concentration is provided for each.” Para. 0123 (emphasis added).
“The precise pH and buffer molar concentration is not critical. As an example, the following components can be added to a 50 mM sodium phosphate--citrate buffer, pH 6.0. (1) A carbohydrate such as 0.3% glycogen [Type II, from Oyster; Sigma-Aldrich, St. Louis, Mo.]. Suitable alternatives are 0.3% alpha-methyl cellulose (Amresco, Solon, Ohio) or 0.3% trehalose (Sigma-Aldrich, St. Louis, Mo.). Although alginates do not independently have the required properties (e.g., ability to withstand the heat of antigen retrieval or resistance to organic solvents), they can suffice (albeit less optimally) as the carbohydrate. The same is true for chitosan as well. (2) A protein, although not all promote adherence of beads to the glass slides. Suitable proteins include 0.3% keyhole limpet hemocyanin (KLH, Calbiochem/EMD Millipore, Billerica, Mass.), glutathione-S-transferase, and 0.3% goat gamma globulin (Sigma-Aldrich, St. Louis, Mo.). (3) Collagen. Examples of collagen include solubilized type I (Rat tail collagen solution, GIBCO/Life Technologies, Grand Island, N.Y.] or solubilized type IV collagen (Fluka/Sigma-Aldrich, St. Louis, Mo.), both of which would be added to a final concentration of approximately 0.01-0.2 mg/mL. (4) A non-ionic detergent. The non-ionic detergent helps promote spreading of the drop after being dispensed onto a microscope slide. An example is 0.0125% (final concentration) n-Octyl Beta-D-Gluco-Pyranoside (Sigma-Aldrich, St. Louis, Mo.). (5) An anti-microbial preservative, such as 0.1% sodium azide or 0.1% ProClin 300. These components can be dissolved in other buffers as well, such as phosphate buffered saline, pH 7.4.” Para. 0124 (emphasis added).
Thus Applicant’s specification (such as in paragraphs 0014, 0030, 0031, 0123, and 0124) supports that the liquid matrix comprises at least one of the disclosed protein and one of the disclosed a carbohydrate. However, the specification lacks sufficient support for the liquid matrix comprising only one of the disclosed protein or only one of the disclosed carbohydrate.
, Applicant’s specification specifically discloses that “[a]lthough alginates do not independently have the required properties (e.g., ability to withstand the heat of antigen retrieval or resistance to organic solvents), they can suffice (albeit less optimally) as the carbohydrate. The same is true for chitosan as well….” (Para. 0124, emphasis added). That is, Applicant’s specification specifically discloses that alginate alone or chitosan alone would not result in the claimed function of the beads remain adhered during the incubation step at a temperature greater than 60 degrees Centigrade. Yet, Applicant’s claim (see for example, claim 11) encompasses requiring only alginate, or only chitosan.
Enablement
Claims 11-12, 14-17, and 57-64 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 the composition forming the solid film as disclosed in paragraphs 0030, 0031, and 0124-127, does not reasonably provide enablement for a “solid film” recited in claims 11, 57, and 58 that encompass only a protein or alternatively only a carbohydrate specifically recited, as opposed to encompassing both a protein and a carbohydrate specifically recited.
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 use the invention commensurate in scope with these claims.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. Factors to be considered in determining whether a disclosure would require undue experimentation include (1) the nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the quantity of experimentation necessary, (7) the relative skill of those in the art, and (8) the breadth of the claims.
The nature of the invention –
Claim 11 recites “a solid film formed from a liquid matrix in which beads are suspended, the liquid matrix being liquid at room temperature and solidifying after application to a solid surface, wherein the solid film directly adheres the beads to the solid surface such that at least some of the beads remain adhered during an incubation step at a temperature greater than 60 degrees Centigrade, a liquid matrix comprising at least one material selected from the group consisting of soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, gamma globulin, glycogen, methyl cellulose, trehalose, chitosan, and alginate…” (emphasis added). [Examiner notes that this claim requires only one of the recited materials, as opposed to both a protein and a carbohydrate specifically recited.]
Claim 57 recites “a solid film formed from a liquid matrix in which beads are suspended, the liquid matrix being liquid at room temperature and solidifying after application to a solid surface, wherein the solid film directly adheres the beads to the solid surface such that at least some of the beads remain adhered during an incubation step at a temperature greater than 60 degrees Centigrade, the liquid matrix comprising at least one material selected from the group consisting of soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, gamma globulin, glycogen, methyl cellulose, trehalose, chitosan, and alginate…” (emphasis added). [Examiner notes that this claim requires only one of the recited materials, as opposed to both a protein and a carbohydrate specifically recited.]
Claim 58 recites “the solid film is formed from a liquid matrix comprising soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, gamma-globulin glycogen, methyl cellulose, trehalose, chitosan, or alginate in which the beads are suspended” (emphasis added). [Examiner notes that this claim requires only one of the recited materials, as opposed to both a protein and a carbohydrate specifically recited.]
Claims 59, 61 and 63 each recite “wherein the liquid matrix includes soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, or gamma globulin” (emphasis added). [Examiner notes that while these claims recite specific proteins, these claim does not require any of the carbohydrates listed in the independent claim 11, 57, and 58. In other words, claims 11, 57, 58, 59, 61 and 63 do not require a soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, or gamma globulin, in addition to a carbohydrate listed in claim 11, since they do not recite for example, --wherein the liquid matrix includes a protein selected from….and a carbohydrate selected from…..--]
Claims 60, 62 and 64 recite “wherein the carbohydrate includes glycogen, methyl cellulose, trehalose, chitosan, or alginate.” (Emphasis added). [Examiner notes that claims 60, 62 and 64, while requiring specific the proteins recited in claims 49, 61 and 63, from which depend, respectively, nevertheless do not require any of the carbohydrates listed in the independent claims 11, 57, 58, 60, 62 and 64, since claims 60, 62 and 64 merely refer back to carbohydrates listed in independent claims 11, 57 and 58, respectively that are listed in the alternative to all the recited proteins and carbohydrates.]
State of the prior art—The prior art discloses a solid film with attached beads/particles with
immobilized reagents for use in an assay.
The predictability or lack thereof of in the art – it is not predictable that the solid film may
comprise only one of the recited proteins or only one of the recited carbohydrates. Applicant lists categories of reagents such as in paragraphs 0123, and it is not predictable that any of these reagents by themselves promote adherence of beads in the manner recited in Applicant’s claims.
4) The amount of direction or guidance present-- the scope of Applicant’s claims encompass broad categories (such as those recited in paragraph 0123, i.e., carbohydrate, protein, solubilized collagen, a non-ionic detergent, and an anti-microbial preservative), but Applicant has only given a combination of a few specific examples within those categories.
The presence or absence of working examples – There are some working examples
of compositions which produce the film having the properties recited in claims 11, 57, and 58 (see paragraphs 0030-0031, and 0124-0127 of the specification). However, the scope of claims 11, 57, and 58 are not limited to those compositions.
Applicant’s specification supports that the recited function of the beads remaining adhered during incubation at a temperature greater than 60 degrees Centigrade using one of the disclosed specific proteins and one of the disclosed specific carbohydrates. However, the specification lacks sufficient support (such as examples, experiments, data, etc.) for showing that only one of the disclosed proteins will have the recited function of the beads remaining adhered during incubation at a temperature greater than 60 degrees Centigrade. Similarly, the specification lacks sufficient support for showing that only one of the disclosed carbohydrates will have the recited function of the beads remaining adhered during incubation at a temperature greater than 60 degrees Centigrade.
As mentioned above [under the heading “Written Description”], Applicant’s specification (such as in paragraphs 0014, 0030, 0031, 0123, and 0124) supports that the liquid matrix comprises at least one of the disclosed protein and one of the disclosed a carbohydrate. However, the specification lacks sufficient support for the liquid matrix comprising only one of the disclosed protein or only one of the disclosed carbohydrate.
Rather, Applicant’s specification specifically discloses that “[a]lthough alginates do not independently have the required properties (e.g., ability to withstand the heat of antigen retrieval or resistance to organic solvents), they can suffice (albeit less optimally) as the carbohydrate. The same is true for chitosan as well….” (Para. 0124, emphasis added). That is, Applicant’s specification specifically discloses that alginate alone or chitosan alone would not result in the claimed function of the beads remain adhered during the incubation step at a temperature greater than 60 degrees Centigrade. Yet, Applicant’s claim (see for example, claim 11) encompasses requiring only alginate, or only chitosan.
In short, there is no indication in Applicant’s specification, by itself or in light of the prior art, that the recited function of the beads remaining adhered to a solid film during incubation at a temperature greater than 60 degrees Centigrade can be performed using only one of the disclosed specific proteins or only one of the disclosed specific carbohydrates.
However, each of Applicant’s claims only requires one reagent (as opposed to one of the disclosed proteins in addition to one of the disclosed carbohydrates).
As discussed above, claim 11 requires only one of the recited materials, as opposed to both a protein and a carbohydrate specifically recited.
Similarly, claim 57 requires only one of the recited materials, as opposed to both a protein and a carbohydrate specifically recited.
Likewise claim 58 requires only one of the recited materials, as opposed to both a protein and a carbohydrate specifically recited.
Also, claims 59, 61 and 63, while requiring specific proteins recited, nevertheless do not require any of the carbohydrates listed in the independent claim 11, since the carbohydrates are still merely recited as alternatives to the proteins recited in the independent claims 11, 57 and 58, and dependent claims 59, 61 and 63. In other words, claims 11, 57, 58, 59, 61, and 63 do not require a soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, or gamma globulin, in addition to a carbohydrate listed in claim 11, since they do not recite for example, --wherein the liquid matrix includes a protein selected from….and a carbohydrate selected from…..--.
Also, claims 60, 62 and 64, while requiring specific the proteins recited in claims 49, 61 and 63, from which depend, respectively, nevertheless do not require any of the carbohydrates listed in the independent claims 11, 57, 58, 60, 62 and 64. That is, while claims 60, 62 and 64 depend from claims 59, 61 and 63, respectively, which requires specific proteins, nevertheless none of these claims require a combination of a carbohydrate and a protein recited, since claims 60, 62 and 64, while reciting specific carbohydrates, do not require such carbohydrates. Rather claims 60, 62 and 64 merely refer back to carbohydrates listed in independent claims 11, 57 and 58, respectively that are listed in the alternative to all the recited proteins and carbohydrates. In other words, all of Applicant’s current claims, including claims 59-64, encompass a scope that may be only one reagent, i.e., “at least one material selected from the group consisting of soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, gamma globulin, glycogen, methyl cellulose, trehalose, chitosan, and alginate…” (see independent claims 11, 57 and 58, and dependent claims 59-64; emphasis added).
In other words, while claims 60, 62 and 64 require specific proteins (as recited in claims 59, 61 and 63, from which they depend, respectively), claims 60, 62 and 64 do not require any of the carbohydrates listed in the independent claims 11, 57, 58, 60, 62 or 64, due to claims 60, 62 and 64 merely reciting “wherein the carbohydrate includes glycogen, methyl cellulose, trehalose, chitosan, or alginate”. In other words, claims 11, 57, 58, 60, 62 and 64 do not require glycogen, methyl cellulose, trehalose, chitosan, or alginate in addition to a protein required in claims 59, 61 and 63, since they not recite for example, --wherein the liquid matrix includes a protein selected from….and a carbohydrate selected from…..--]
In summary, each of Applicant’s claims, including the claims mentioned above and any of their dependent claims, only requires one reagent (as opposed to one of the disclosed proteins in addition to one of the disclosed carbohydrates).
Therefore, since the specification lacks sufficient support for showing that only one of the disclosed proteins or only one of the disclose carbohydrates will have the recited function of the beads remaining adhered during incubation at a temperature greater than 60 degrees Centigrade, 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 use the invention commensurate in scope with these claims.
Examiner emphasizes that it is the scope of Applicant’s claims that fail to meet the enablement requirement.
The quantity of experimentation necessary – it would be undue experimentation for a
skilled artisan to make and use the inventions as claimed since there is no guidance as compositions other than the combination of reagents disclosed in paragraphs 0031 and 0124 that meet the properties recited in the rejected claims.
7) The relative skill of those in the art – the level of skill in the art is high since biochemistry is complex and unpredictable.
8) The breadth of the claims –
As mentioned above, each of Applicant’s claims only requires one reagent (as opposed to one of the disclosed proteins in addition to one of the disclosed carbohydrates).
Therefore, since the specification lacks sufficient support for showing that only one of the disclosed proteins or only one of the disclose carbohydrates will have the recited function of the beads remaining adhered during incubation at a temperature greater than 60 degrees Centigrade, 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 use the invention commensurate in scope with these claims.
In sum, the only compositions disclosed for the claimed solid film that has these properties appear to be the combination of reagents (such as disclosed in paragraphs 0031 and 0124) of the specification. However, all the claims require less than the combination of reagents that are disclosed as having the claimed function of having the beads remaining adhered to the solid film during an incubation step at a temperature greater than 60 degrees Centigrade, and therefore the claims are broader in scope that is reasonably supported by the specification. Therefore, 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 or use the invention commensurate in scope with the rejected claims.
Response to Arguments
Applicant has amended the claims and assert that the prior art does not teach the claimed limitations.
However, the claims are rejected for not meeting the written description requirement and enablement requirement for the reasons set forth above.
Examiner notes that Applicant’s amendment of the independent claims 11, 57 and 58 has removed the recitation of a carbohydrate and a protein. All the claims (as discussed above) require only one of the reagents (i.e., one of the recited carbohydrate or protein), as opposed to both a carbohydrate and a protein.
Examiner notes that while claims 60, 62 and 64 were previously indicated as having allowable subject matter, the scope of claims 60, 62 and 64 however have changed due to amendments to the claims from which they depend.
More specifically, claims 59, 61 and 63, while requiring specific proteins recited, nevertheless do not require any of the carbohydrates listed in the independent claim 11, since the carbohydrates are still merely recited as alternatives to the proteins recited in the independent claims 11, 57 and 58, and dependent claims 59, 61 and 63. In other words, claims 11, 57, 58, 59, 61, and 63 do not require a soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, or gamma globulin, in addition to a carbohydrate listed in claim 11, since they do not recite for example, --wherein the liquid matrix includes a protein selected from….and a carbohydrate selected from…..--.
Also, claims 60, 62 and 64, while requiring specific the proteins recited in claims 49, 61 and 63, from which depend, respectively, nevertheless do not require any of the carbohydrates listed in the independent claims 11, 57, 58, 60, 62 and 64. That is, while claims 60, 62 and 64 depend from claims 59, 61 and 63, respectively, which requires specific proteins, nevertheless none of these claims require a combination of a carbohydrate and a protein recited, since claims 60, 62 and 64, while reciting specific carbohydrates, do not require such carbohydrates. Rather claims 60, 62 and 64 merely refer back to carbohydrates listed in independent claims 11, 57 and 58, respectively that are listed in the alternative to all the recited proteins and carbohydrates. In other words, all of Applicant’s current claims, including claims 59-64, encompass a scope that may be only one reagent, i.e., “at least one material selected from the group consisting of soluble collagen, keyhole limpet hemocyanin, glutathione-S-transferase, gamma globulin, glycogen, methyl cellulose, trehalose, chitosan, and alginate…” (see independent claims 11, 57 and 58, and dependent claims 59-64; emphasis added).
In summary, while claims 60, 62 and 64 require specific proteins (as recited in claims 59, 61 and 63, from which they depend, respectively), claims 60, 62 and 64 do not require any of the carbohydrates listed in the independent claims 11, 57, 58, 60, 62 or 64, due to claims 60, 62 and 64 merely reciting “wherein the carbohydrate includes glycogen, methyl cellulose, trehalose, chitosan, or alginate”. In other words, claims 11, 57, 58, 60, 62 and 64 do not require glycogen, methyl cellulose, trehalose, chitosan, or alginate in addition to a protein required in claims 59, 61 and 63, since they not recite, for example, --wherein the liquid matrix includes a protein selected from….and a carbohydrate selected from…..--]
Therefore, since the specification lacks sufficient support for showing that only one of the disclosed proteins or only one of the disclose carbohydrates will have the recited function of the beads remaining adhered during incubation at a temperature greater than 60 degrees Centigrade, the specification does not provide sufficient written description to support the claims and does not enable a person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Conclusion
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/Ann Montgomery/ Primary Examiner, Art Unit 1678