DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-58 have been canceled.
Claims 59-72 are pending and under examination.
Claim Objections
Claim 59 is objected to because of the following informalities: please provide full name of SMN (survival of motor neuron protein). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 67-72 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.
As to claim 67, the compound in the claim is either TNFalpha or LPS. It is noted that claim 67 depends on claim 64 which directs to a compound capable of inhibiting protein synthesis. However TNFalpha or LPS are not known for inhibiting protein synthesis. It is believed that claim 67 may depend on claim 66 which refers to enzymatic activity of p38 MAPK in a cell. Please clarify.
As to claim 68, this claim depends on a canceled claim 58. For the prior art purpose, examiner would consider claim 68 depending on claim 59.
As to claim 71, line 2, “said camera” lacks antecedent basis.
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 59-60, 63, 65, 69, 70 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.
With the above instruction, main claim 59 would be interpreted a kit having ANY ingredients or compounds that are capable involving measuring SMN complex component in a cell. Under broadest reasonable interpretation, any similar (or functionally similar) materials used in the application, can be considered as prior art even with a different purpose. For instance, confocal microscope using for visualization (see section 0049 from specification, claim 69 visualization means), or P38 (MARK)(which can enzymatically activates SMN complex) inducers, such as LPS or TNFalpha, phenylephrine, or gonadotropin releasing hormone (GnRH) (see section 0079 from specification, claim 67-68) or SMN antibodies (section 0160), the aforementioned ingredients or tool can all be considered “means” for measuring SMN complex component. Applicant is reminded that a recitation of the intended use of the claimed invention, i.e. measuring relocation of SMN complex, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 59-63 and 68-71 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Dreyfuss (I) (US 20060223092).
Dreyfuss teaches study SMN complex in a cell sample. Several antibodies are useful for detecting SMN complex, including anti-SMN (62E7), anti-Gemin2 (2E17), anti-Gemin3 (12H12), anti-Gemin4 (17D10), anti-Gemin5 (10G11), anti-Y14 (IF12) and anti-Sm (Y12) monoclonal antibodies (section 0127). Note, applicants state “[0050] In another embodiment, the SMN complex component is a Gem. In another embodiment, Gems are discrete SMN complex bodies in the nucleus. In another embodiment, “an SMN complex component” comprise, in addition to SMN, other proteins termed “Gemins.”. Thus those antibodies disclosed by Dreyfuss can be considered ligands capable of measuring SMN complex.
Moreover, Dreyfuss also teach using tetracycline (i.e. protein inhibitor) for the test (section 0128-0129). In addition, Dreyfuss further teaches placing the necessary ingredients into a kit (Abstract; section 0039, 0047 and 0068). Taken together, the above ingredients are the SAME ingredient used in the current kit as means for measuring SMN complex (emphasis added).
As to claim 68, applicant is reminded that a recitation of the intended use of the claimed invention, i.e. measuring relocation of SMN complex, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Although Dryefuss does not explicitly teach using the above ingredients testing compound(s) for modulating p38(MARK) activity, nevertheless the SAME ingredient and visualization camera can still be considered means for measuring SMN complex in a cell as held in the case law above.
As to claim 62, Dreyfuss also uses 2B1 monoclonal antibody (section 0100).
As to claim 63, tetracycline (i.e. protein inhibitor) is used (section 0128-129).
As to claim 69-71, microscopy and imaging system are used for visualization of results (section 0103 and 0127).
Claim(s) 59, 68-71 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kortum (US 20020127632).
Claim 59 directs to a kit having means for measuring SMN complex. One of the means in the specification is using confocal microscopy (spec section 0049).
Kortum teaches using agent, such as acetic acid, to enhance cellular detection in confocal microscopy (see abstract). Kortum shows that an increased contrast between the relative nucleus and cytoplasm signal intensities (see section 0074; Figure 9). The confocal microscopy includes camera, microscopy and inherently computer system receiving data images from the camera (see Figure 9).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 72 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kortum.
Claim 72 directs to the computer system in the imaging system comprising algorithms software for analysis relative signal intensities of cytoplasm and nucleus. Although Kortum does not explicitly disclose such computer algorithms, nevertheless it would have been prima facie obvious to one ordinary skilled in the field to incorporate the computation algorithm in the confocal imaging system because Kortum can discern an increase contrast between nucleus and cytoplasm in Figure 9. Such observation would have been prima facie obvious as the results of calculating the imaging data (e.g. relative intensity) by computer algorithms for both cytoplasm and nucleus, respectively.
Claim 59, 63-64 and 66-68 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bonavida (US 20010053772) in view of Zuk (US 4208479).
Bonavida teaches measuring cytokines and alkyl lysophospholipid in identifying therapeutic candidate for treating a subject (see abstract). Bonavida teaches measuring TNFα (with standard human recombinant TNFα)(also read on claim 67-68 was used by applicant in increasing p38(MAPK) activity in cell) and on the effect of cycloheximide (See Examples 1-2 and 6; Figures 3-5)(also read on claim 63-64). Although Bonavida does not explicitly teach placing all the ingredients in a kit, nevertheless it is well-known and commonly practiced in the field to do so for convenience and reproducibility.
For instance, Zuk teaches that in performing assays, it is convenient and to combine the necessary reagents together in a kit (col. 22, lines 20-35). Zuk further teaches that this may improve assay accuracy.
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to have TNFalpha and cycloheximide into a kit as taught by Zuk et al. for convenience, standardization, and improved accuracy. The above ingredients are suitable in a kit for testing a candidate compound having potential to modulating p38(MAPK) enzymatic activity in a cell (see case law of “intended use” above).
As to claim 63-64, cycloheximide is used and capable of inhibiting protein synthesis (see above).
As to claim 66-68, same TNFalpha is used and inherently capable of increasing enzymatic activity of p38 MAPK in a cell (see above case law “intended use”).
Claim 59-61 and 68-72 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mazarakis (US 20040076613) in view of Zuk.
Mazarakis teaches detecting SMN complex in cells. Mazarakis teaches SMN antibody (see section 0449). Mazarakis uses confocal microscopy in observing the restoration (retrograde transport) of SMN in fibroblast cells (See Figure 35A and 35 B) where Mazarakis notes “strong staining in the cytoplasm and nucleus” (see section 0093). At least both the SMN antibody and confocal microscopy (visualization means) can be considered means the claims 59-61. Although Mazarakis does not explicitly teach placing all the necessary materials in a kit, nevertheless it is well-known and commonly practiced in the field to do so for convenience and reproducibility.
For instance, Zuk teaches that in performing assays, it is convenient and to combine the necessary reagents together in a kit (col. 22, lines 20-35). Zuk further teaches that this may improve assay accuracy.
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to have antibody into a kit as taught by Zuk et al. for convenience, standardization, and improved accuracy.
As to claim 72 directing a computer having imaging software for analysis of parameters of relative nuclear signal intensity and relative cytoplasmic signal intensity, such features can be prima facie to one ordinary skilled person in the art viewing the disclosure of Mazarakis. It is because Figure 35A and 35B Mazarakis notes “strong staining in the cytoplasm and nucleus” (see section 0093). This means that the imaging system can detect areas of cytoplasm and nuclear and it would have been prima facie to one ordinary skilled in the field to record and analyze the relative intensities in these two areas via computer algorithms software.
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).
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 reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 59-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10738345 in view of Zuk and Dreyfuss. Although the claims at issue are not identical, they are not patentably distinct from each other because the 345’ patent directs to same method of screening a candidate compound for its potential affect on MAPK enzymatic activity by means of measuring the relocation of SMN complex component in a cell. The 345’ patent using ligand antibody, anisomycin protein synthesis inhibitor, visual microscope and imaging data collection for detection. Although 345’ directs to a method, nevertheless it would have been prima facie obvious to one ordinary skilled person in the field to place all the necessary ingredients as means for carrying out the method, such as taught by Zuk (see above). As to the specific antibody 2B1 (claim 62), although 345’ does not explicitly teach using this particular antibody for detecting SMN complex, nevertheless Dreyfuss teaches using 2B1 antibody for detecting SMN complex (see above). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 2B1 antibody specific for SMN complex as taught by Dreyfuss to measure SMN compex because using an alternative but having same functionality of antibody for detecting a known target is merely a routine practice in the field and one artisan would have reasonable expectation of success.
Claims 59-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 are of U.S. Patent No. 8802380 in view of Zuk and Dreyfuss. Similarly 380’ patent also directs to screening a candidate compound for its potential affect on MAPK enzymatic activity by means of measuring the relocation of SMN complex component in a cell. The 380’ patent using ligand antibody, anisomycin protein synthesis inhibitor, fluorescent label, visual microscope and imaging data collection for detection. Although 380’ directs to a method, nevertheless it would have been prima facie obvious to one ordinary skilled person in the field to place all the necessary ingredients as means for carrying out the method, such as taught by Zuk (see above). As to the specific antibody 2B1 (claim 62), although 380’ does not explicitly teach using this particular antibody for detecting SMN complex, nevertheless Dreyfuss teaches using 2B1 antibody for detecting SMN complex (see above). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 2B1 antibody specific for SMN complex as taught by Dreyfuss to measure SMN compex because using an alternative but having same functionality of antibody for detecting a known target is merely a routine practice in the field and one artisan would have reasonable expectation of success.
Claims 59-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 are of U.S. Patent No. 8227203 in view of Zuk and Dreyfuss. Similarly 203’ patent also directs to screening a candidate compound for its potential affect on MAPK enzymatic activity by means of measuring the relocation of SMN complex component in a cell. The 203’ patent using ligand antibody, anisomycin protein synthesis inhibitor, fluorescent label, visual microscope and imaging data collection for detection. Although 203’ directs to a method, nevertheless it would have been prima facie obvious to one ordinary skilled person in the field to place all the necessary ingredients as means for carrying out the method, such as taught by Zuk (see above). As to the specific antibody 2B1 (claim 62), although 203’ does not explicitly teach using this particular antibody for detecting SMN complex, nevertheless Dreyfuss teaches using 2B1 antibody for detecting SMN complex (see above). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 2B1 antibody specific for SMN complex as taught by Dreyfuss to measure SMN compex because using an alternative but having same functionality of antibody for detecting a known target is merely a routine practice in the field and one artisan would have reasonable expectation of success.
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678