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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 10-14, in the reply filed on 11/04/25 is acknowledged. The traversal is on the ground(s) that there is no undue administrative burden for the Examiner to search and consider as the corresponding PCT Written Opinion reveals searched all claims 1-14 without raising any issue relating to lack of Unity of Invention, and the claims were indicated to be novel and non-obvious.
First, the test of establishing burden is strictly a test for restriction issued under 35 U.S.C. 121, which is not applicable in the case of a 371 application. It is also noted that the issuance of the type of Office Action (i.e. Rejection, Notice of Allowance) is not bound to the WO report due to different examination procedure and statute.
Regarding, the lack of Unity of Invention, as provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
However, the apparatus of claim 10 (the common feature between independent claim 10 and 11) is only capable of performing part of the process outlined in Group I/claim 1. The apparatus in claim 10, as claimed, does not disclose the capability of conducting analysis and determining the composition and/or structure of the glycan molecules of claim 1. As a result, Group I and II cannot be qualified under (4) A process and an apparatus or means specifically designed for carrying out the said process, as the apparatus in Group II, as claimed, is capable carrying out only part of the process.
For the reason above, Examiner believes that the claims are not drawn to any of the combinations above and lack of Unity is appropriate and has proceeded to outline the common technical feature does not make a contribution over the prior art in view of Yang (US 20150168415 A1) as discussed in the previous Office Action.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: hydrolysis unit and derivatization unit in claims 10 and 11.
Applicant discloses the hydrolysis unit includes a first reservoir A containing a solution of the glycan molecule, a first reservoir containing an acidic solution, a first reactor and a first collection valve, connected with connective tubing (para. [0071]).
Applicant discloses the derivatization unit includes a second reservoir A containing the fluorescent label, a second reservoir B, a mixer, a derivatization reactor and a second collection valve, connected with connective tubing (para. [0072]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: means for comparing the one or more characteristics…to determine the composition and sugar sequence of the glycan molecule in claim 11.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waters (U.S. Pub. No. 2016/0195564 A1) in view of Ruhaak (U.S. Pub. No. 2012/0244625 A1).
Regarding claim 10, Waters discloses a flow chemistry system for carbohydrate analysis (system 1, Figure 1), comprising:
a unit includes a first reservoir A containing a solution of a sample (first sample loop 40, Fig. 2), a first reservoir containing a reagent (reagent reservoir 50), a mixer (tee mixer 18, Fig. 2), a reactor (microreactor 12, Fig. 2) and a collection valve (reagent valve 28, Fig. 2), connected with connective tubing (In addition, unless otherwise specified, all connections are fluidic and provide for fluid flow, including but not limited to, tubing connections between fluidic ports and devices such as the reactor, the reactor flow stream, valves, pumps, reservoirs and other apparatus that are described herein. Para. [0052]).
Waters do not disclose a second unit including a second reservoir A, a second reservoir B, a reactor and a second collection valve, connected with connective tubing.
Furthermore, Waters does not disclose hydrolysis unit includes a first reservoir A containing a solution of the glycan molecule, a first reservoir containing an acidic solution and the derivatization unit the derivatization unit includes a second reservoir A containing the fluorescent label, a second reservoir B containing the product produced by the hydrolysis unit.
Regarding incorporation of a second unit including a second reservoir A, a second reservoir B, a reactor and a second collection valve, connected with connective tubing, wherein the second reservoir B is configured to receive the product from the reaction of the unit, Waters discloses the flow chemistry system can be modified to include multiple reaction unit sequentially and in series (Samples can be taken from one or more non-pressurized sources (reactors, reactor flow streams, and the like) sequentially or simultaneously, in series or in parallel. Para. [0090]) and it would have been within the skill of one of ordinary skill in the art to have modified the device to fit the proper application (para. [0131]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated a second unit connected with a first unit in order to enable a sequential reactions application.
Regarding the limitation of derivatization unit including a second reservoir A containing the fluorescent label, Waters disclose the microreactors of the flow chemistry system is ideal for derivatization reaction including the addition of a chromophore or fluorescent functional group (para. [0108]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated a derivatization unit with reagent reservoir including a fluorescent label as taught by Waters. Incorporating a step of derivatization chemistry enable better detectability and enhanced separation for the analysis of an analyte (Advantages of derivatization include improved detectability, change in molecular structure of analyte for better chromatography, increase volatility, change the matrix for better separation and stabilization an analyte. Para. [0109]).
Regarding the limitation of hydrolysis unit including a first reservoir A containing a solution of the glycan molecule, a first reservoir containing an acidic solution, Waters discloses the flow system, with the right reagents, can be used for rapid tagging and analysis of glycans such as N-linked glycan using liquid chromatography, mass spectrometry, fluorescence and UV detection (para. [0111]). Furthermore, it is known in the art that efficacy of chromatography or spectrometry improves when a complex structure is being fragmented.
In an analogous art, Ruhaak discloses a method for carbohydrate analysis (para [0049] -'...Labeled N-glycans were analyzed using HILIC-HPLC with fluorescence detection...'),
wherein the method comprises: a means of hydrolysis (para [0042] - '...A glucose ladder was produced by partial acid hydrolysis of 10 mg of dextran...') using 1 mL of 1M TFA (acidic solution);
a means of derivatization (para [0077] - '... For glycan analysis by CE-LIF or CE-MS, derivatization of glycans with the APTS label is favourable since it has three sulfonic acids, which generate three negative charges...'); and
a means of labeling a carbohydrate (Abstract - '...also describes a process for labeling a carbohydrate, 9 the process comprising contacting the carbohydrate with a labeling agent...'; para [0032] - '...The reaction of the carbohydrate with labelling agent and 2-PB may be carried out at any suitable reaction temperature for any suitable length of time....').
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporate reagents for hydrolysis of glycan as taught by Ruhaak for the first reservoir to derived the claimed invention. Waters discloses the potential/ability to analyze labeled N-glycan in the flow chemistry system. Incorporating a step of partial hydrolysis of carbohydrate in the hydrolysis unit with appropriate reagents as taught by Ruhaak would allow for complex carbohydrate structure to be fragmented, which would have improved the effectiveness of subsequent chromatographic and spectrometric analysis.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waters in view of Ruhaak and Yu (N-linked Glycan Characterization and Profiling: Combining the Power of Accurate Mass, Reference Glucose Units, and UNIFI Software for Confident Glycan Assignment).
Regarding claims 11-14, Waters discloses a flow chemistry system for carbohydrate analysis, comprising:
a flow chemistry system, comprising:
a unit includes a first reservoir A containing a solution of a sample (first sample loop 40, Fig. 2), a first reservoir containing a reagent (reagent reservoir 50), a mixer (tee mixer 18, Fig. 2), a reactor (microreactor 12, Fig. 2) and a collection valve (reagent valve 28, Fig. 2), connected with connective tubing (In addition, unless otherwise specified, all connections are fluidic and provide for fluid flow, including but not limited to, tubing connections between fluidic ports and devices such as the reactor, the reactor flow stream, valves, pumps, reservoirs and other apparatus that are described herein. Para. [0052]);
an analytical system adapted for interaction with flow chemistry system for the measurement of one or more characteristics of sugar derivatives, wherein the measurement is performed by NMR, LC, GC, MS and any combination thereof (para. [0040]);
Waters do not disclose a second unit including a second reservoir A, a second reservoir B, a reactor and a second collection valve, connected with connective tubing. Waters also does not disclose hydrolysis unit includes a first reservoir A containing a solution of the glycan molecule, a first reservoir containing an acidic solution and the derivatization unit the derivatization unit includes a second reservoir A containing the fluorescent label, a second reservoir B containing the product produced by the hydrolysis unit. Furthermore, Waters does not disclose the claimed data processing system.
Regarding incorporation of a second unit including a second reservoir A, a second reservoir B, a reactor and a second collection valve, connected with connective tubing, wherein the second reservoir B is configured to receive the product from the reaction of the unit, Waters discloses the flow chemistry system can be modified to include multiple reaction unit sequentially and in series (Samples can be taken from one or more non-pressurized sources (reactors, reactor flow streams, and the like) sequentially or simultaneously, in series or in parallel. Para. [0090]) and it would have been within the skill of one of ordinary skill in the art to have modified the device to fit the proper application (para. [0131]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated a second unit connected with a first unit in order to enable a sequential reactions application.
Regarding the limitation of derivatization unit including a second reservoir A containing the fluorescent label, Waters disclose the microreactors of the flow chemistry system is ideal for derivatization reaction including the addition of a chromophore or fluorescent functional group (para. [0108]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated a derivatization unit with reagent reservoir including a fluorescent label as taught by Waters. Incorporating a step of derivatization chemistry enable better detectability and enhanced separation for the analysis of an analyte (Advantages of derivatization include improved detectability, change in molecular structure of analyte for better chromatography, increase volatility, change the matrix for better separation and stabilization an analyte. Para. [0109]).
Regarding the limitation of hydrolysis unit including a first reservoir A containing a solution of the glycan molecule, a first reservoir containing an acidic solution, Waters discloses the flow system, with the right reagents, can be used for rapid tagging and analysis of glycans such as N-linked glycan using liquid chromatography, mass spectrometry, fluorescence and UV detection (para. [0111]). Furthermore, it is known in the art that efficacy of chromatography or spectrometry improves when a complex structure is being fragmented
In an analogous art, Ruhaak discloses a method for carbohydrate analysis (para [0049] -'...Labeled N-glycans were analyzed using HILIC-HPLC with fluorescence detection...'),
wherein the method comprises: a means of hydrolysis (para [0042] - '...A glucose ladder was produced by partial acid hydrolysis of 10 mg of dextran...') using 1 mL of 1M TFA (acidic solution);
a means of derivatization (para [0077] - '... For glycan analysis by CE-LIF or CE-MS, derivatization of glycans with the APTS label is favourable since it has three sulfonic acids, which generate three negative charges...'); and
a means of labeling a carbohydrate (Abstract - '...also describes a process for labeling a carbohydrate, 9 the process comprising contacting the carbohydrate with a labeling agent...'; para [0032] - '...The reaction of the carbohydrate with labelling agent and 2-PB may be carried out at any suitable reaction temperature for any suitable length of time....').
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporate the appropriate reagents for glycan hydrolysis as taught by Ruhaak for the first reservoir to derived the claimed invention. Waters discloses the potential/ability to analyze labeled N-glycan in the flow chemistry system. Incorporating a step of partial hydrolysis of carbohydrate in the hydrolysis unit with appropriate reagents as taught by Ruhaak would allow for complex carbohydrate structure to be fragmented, which would have improved the effectiveness of subsequent chromatographic and spectrometric analysis.
Regarding the claimed data processing system, Yu (also by Waters) discloses a data processing system for N-glycan analysis performed by chromatography/MS. The data processing system comprises sugar database (Scientific library, Fig. 1, Page 7) and a means for comparing the one or more characteristics of sugar derivatives measured by the analytical system with sugar database (Step 2: Data processing and scientific library search, Page 9-11) to determine the composition and sugar sequence of the glycan (Fig. 5-6; Practical application: Using UNIFI Scientific Information System to compare N-glycan profiles of an innovator biotherapeutic and a biosimilar candidate, Page 12-13). It would have been obvious to one of ordinary skill in the art before the effective date to have integrated Waters’s own data processing system (as taught by Yu) to the device of Waters to derive the claimed invention, doing so enable a compliant-ready, automated, high-confidence glycan structure assignments by enabling rapid acquisition, review, and communication of individual glycan profile results, and the larger sets of glycan analyses used for comparability studies (Conclusion, Page 15).
Conclusion
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/M.H./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758