DETAILED ACTION
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
Claims 20-34 are pending and are examined.
Priority
Applicant claims for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. When examining the long and convoluted chain of priority claims it is noted that the first mention of an anti-vinculin antibody is made in the provisional Application 61/701,923, filed 09/17/2012. As a consequence, the earliest priority date for this particular Application is going to be considered 09/17/2012.
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.
Claims 21-23 and 33-34 ae rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are drawn to a method of detecting the presence or absence of an antibody capable of binding specifically to vinculin (having the sequence of SEQ ID NO:1) or a fragment thereof, comprising: obtaining a biological sample from a subject having a symptom of post-infectious irritable bowel syndrome (PI-IBS); and detecting the presence or absence of the antibody capable of binding specifically to vinculin or a fragment thereof by contacting vinculin or the fragment thereof to the biological sample, and detecting a signal that indicates the presence of the antibody capable of binding to vinculin or a fragment thereof.
The specification indicates that SEQ ID NO: 1 is Cytolethal distending toxin subunit B (CdtB) of Campylobacter coli ([0023]).
There is no indication in the art that an anti-vinculin would bind a protein of SEQ ID NO: 1 and the specification does not show any binding of an anti-vinculin antibody to CdtB. The specification shows that the vinculin has a sequence represented by SEQ ID NO: 7. Due to the lack of homology between SEQ ID NO: 1 and SEQ ID NO: 7(see attached alignment) it is extremely improbable that an antivinculin antibody would bind to a protein of SEQ ID NO: 1. Thus, a person of ordinary skill in the art would be put in the unenviable task of trying to use the method claimed with extremely little expectation of success. Thus, a skilled artisan would conclude that the claims 21-23 and 32-34 are not enabled.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, the claim mentions: “… wherein assaying comprises contacting vinculin or a fragment thereof with the biological sample to detect the presence or absence of the antibody.” In the independent claim 20, “… detecting the presence or absence of the antibody capable of binding specifically to vinculin or a fragment thereof by contacting vinculin or the fragment thereof to the biological sample, and detecting a signal that indicates the presence of the antibody capable of binding to vinculin or a fragment thereof.” Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 20, 24, 25, 27-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of the U.S. Patent No. 9,702,884. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the U.S. Patent are drawn to a method comprising: providing a biological sample from a subject desiring diagnosis regarding irritable bowel syndrome (IBS); detecting in the biological sample, a level of an anti-vinculin antibody, wherein detecting comprises using vinculin, SEQ ID NO:1 or a fragment thereof to detect the anti-vinculin antibody; determining a presence or likely presence of IBS if the level of the anti-vinculin antibody is higher than an established control level, or determining an absence or likely absence of IBS if the level of the anti-vinculin antibody is equal to or lower than an established control level, wherein the established control level is determined from a group of healthy subjects, a group of subjects with inflammatory bowel disease, or a group of subjects who are either healthy or have inflammatory bowel disease; and selecting a therapy for IBS if the presence or likely presence of IBS is determined.
Regarding the limitations of claim 31 (the patient is a human patient, the claims would be obvious in view of the fact that most therapeutical procedures are geared towards human treatments of diseases.
In the broadest reasonable interpretation the method has the same method steps and goal (detecting vinculin auto-antibodies) as a marker for IBS and thus anticipates the instant claims 20, 24, 25, 27-29 and 32.
Claims 20, 24, 27, 28 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 6-8 of U.S. Patent No. 9,851,361. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the U.S. Patent comprises measuring anti-vinculin auto-antibodies in a patient having IBS and selecting the patient for further treatment.
In the broadest reasonable interpretation the method has the same method steps and goal (detecting vinculin auto-antibodies) as a marker for IBS and thus anticipates the instant claims 20, 24, 27, 28 and 32.
Claims 20, 24, 27-29 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9,952,223. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the U.S. Patent are drawn to a method of detecting anti-vinculin antibodies, comprising: obtaining a biological sample from a subject desiring a diagnosis regarding irritable bowel syndrome (IBS); detecting in the biological sample, a level of the anti-vinculin antibodies.
In the broadest reasonable interpretation the method has the same method steps and goal (detecting vinculin auto-antibodies) as a marker for IBS and thus anticipates the instant claims 20, 24, 27-29 and 32.
Claims 20, 24-27, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-8 of U.S. Patent No. 10,132,814 Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the U. S. Patent comprises measuring anti-vinculin auto-antibodies in a patient having IBS and selecting the patient for further treatment.
In the broadest reasonable interpretation the method has the same method steps and goal (detecting vinculin auto-antibodies) as a marker for IBS and thus anticipates the instant claims 20, 24-27 and 32.
Claims 20, 24, 27-29 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10, 352,944. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the U.S. Patent comprises measuring anti-vinculin auto-antibodies in a patient having IBS and selecting the patient for further treatment.
In the broadest reasonable interpretation the method has the same method steps and goal (detecting vinculin auto-antibodies) as a marker for IBS and thus anticipates the instant claims 20, 24, 27-29 and 32.
Claims 20, 24-26 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,690,679. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the U.S. Patent are drawn to an assay system that comprises a biological sample obtained from a subject desiring a diagnosis to distinguish IBS from both IBD and celiac disease, vinculin or a fragment thereof and cytolethal distending toxin subunit B (CdtB) or a fragment thereof; and one or more assays to detect in the biological sample, levels of anti-vinculin antibodies and anti-cytolethal distending toxin subunit B (CdtB) antibodies; the biological sample is whole blood, serum, or plasma.
In the broadest reasonable interpretation the method has the same method steps and goal (detecting vinculin auto-antibodies) as a marker for IBS and thus anticipates the instant claims 20, 24-26 and 32.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647