Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Status of Application and Claims
US Patent 11,435,361 issued on 9/6/22 with claims 1-15. This reissue application was filed on 9/5/24 amending claim 1 and adding claims 16-35. Claims 1-35 are under examination on their merits.
Applicant is requested to supply a full claim listing each time in order to assist with record clarity.
Establishment of Ownership and Consent of Assignee
This reissue application was filed with a form PTO/AIA /96 Statement Under 37 CFR 3.73(c), but this form fails to properly establish ownership because the fields for the patent number and issue date were left blank. Because ownership has not been properly established, the consent to reissue is defective.
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.
Claims 1-18 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.
Claim 1 refers to “FERM domain-containing protein 8 (CD8).” This is confusing because in the biological arts, the abbreviation for FERM domain-containing protein 8 is FRMD8, not CD8. FRMD8 was known in the art as a protein involved in positive regulation of tumor necrosis factor production. CD8 (Cluster of Differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). The meaning of the material within the parentheses at line 6 of amended claim 1 is therefore unclear. Because claims 2-18 depend from claim 1 and do not rectify the indefiniteness, they must also be rejected under 35 U.S.C. 112, second paragraph.
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 1-35 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 1 is drawn to a method of detecting the amount of Alzheimer’s disease diagnostic autoantibodies in a subject comprising a step of contacting a biological sample from the subject with a substrate containing at least two antigens selected from the group consisting of FRMD8,1 LGALS1, DnaJ homolog subfamily C member 8, ADARB1, ASXL1, and JMJD2D. Claim 19 is similar but requires contacting a biological sample from the subject with a substrate containing at least two antigens selected from the group consisting of ADARB1, ASXL1, and JMJD2D. This rejection addresses the embodiments in which one of the antigens is JMJD2D. The skilled artisan would not have concluded that applicant possessed the claimed invention.
The ’361 patent generally describes diagnostic autoantibody profiles for the detection of neurodegenerative disease. The ’361 patent provides Table 1, a list of what appears to be at least several hundred “potentially useful diagnostic indicators” of Alzheimer’s disease (AD). (Columns 12-39.) The ’361 patent also identifies a preferred embodiment in which the protein antigens of Table 4 are diagnostic for AD. (Column 41.) Table 4 contains FRMD8, ADARB1, LGALS1, DnaJ homolog subfamily C member 8, and ASXL1. (Lines 8-12,16, and 18-19.) The marker JMJD2D, however, is absent from the preferred embodiment in Table 4. The ’361 patent lists JMJD2D only within Table 1 (column 25, eighth marker from bottom of page) and Table 7 (column 77, fifth marker from bottom of page).
The ’361 patent describes “M-Statistical Analysis,” a calculation that evaluates the diagnostic significance of a given protein. (Column 48, lines 55-59.) The ’361 patent identifies JMJD2D within Table 7 as having a “P-Value” of 0.010846, compared to a “P-Value” of less than 10-10 for the markers FRMD8, DnaJ homolog subfamily C member 8, and ASXL1. (Compare column 77, fifth marker from bottom of page, with column 52, first several entries.) Nothing in Table 7 clearly identifies JMJD2D as being particularly diagnostic for AD; indeed, Table 7 does not highlight JMJD2D in any way. The person of ordinary skill in the art considering the ’361 patent would therefore not have concluded that applicant possessed a method of detecting AD-diagnostic autoantibodies including JMJD2D.
Claim Rejections - 35 USC § 251
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are “for the invention disclosed in the original patent” as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. The ’361 patent does not meet the requirements of 35 U.S.C. 112(a) for the reasons set forth above. Furthermore, the inclusion of JMJD2D on a list of several hundred markers with no particularly relevant P-value does not indicate that applicant intended to claim JMJD2D as an AD-diagnostic marker.
Therefore, claims 1-35 do not satisfy the “original patent” requirement.
Claims 1-35 are rejected under 35 U.S.C. 251 for not claiming subject matter directed to the invention disclosed in the original patent.
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 1-5 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, and 7 of U.S. Patent No. 9,664,687 in view of Amaral et al. (US 20060292640; reference A).
The ’687 patent claims a method for detecting neurodegenerative disease diagnostic autoantibodies in a subject by (a) obtaining an immunoglobulin-containing biological sample from the subject and (b) performing an assay on the sample to determine the presence of autoantibodies. The assay step comprises forming immunocomplexes between autoantibodies comprising at least two antigens that may be JMJD2D and LGALS1, then detecting the presence of the immunocomplexes. (Claim 1.)
The ’687 patent does not claim that the immunocomplexes are labeled.
Amaral teaches that labeled secondary antibodies are generally used in the art to detect autoantibodies in a sample that have bound to one or more antigens. Amaral teaches that secondary antibodies bind to immunoglobulins and can be labeled with any directly or indirectly detectable moiety, e.g. a fluorophore, an enzyme, a radioisotope, or a chemiluminescent moiety. (Paragraph 37.) Amaral teaches that the amount of autoantibody-antigen complex can be quantified using a digital imager, x-ray film developer, or automated plate reader using methods well known in the art. (Paragraph 38.)
It would have been obvious to use detect the immunocomplexes using a label such as Amaral’s labeled secondary antibodies to bind the autoantibody-antigen complex of the ’687 patent because Amaral teaches that these reagents are useful for detecting binding between autoantibodies and their antigens. The person of ordinary skill in the art would have been motivated to make the combination in order to permit quantification of autoantibody-antigen binding.
Examined claims 2-4 correspond to claims 3-5, respectively, of the ’687 patent.
Regarding examined claim 8, the ’687 patent claims that the assay may evaluate PTCD2. (Column 111, line 65.)
Regarding examined claim 9, the ’687 patent claims that the assay may evaluate ANKHD1 transcript variant 3. (Column 112, lines 7-8.)
Regarding examined claim 10, the ’687 patent claims that the assay may evaluate cDNA clone MGC:31944 IMAGE:4878869 complete cds. (Column 112, line 35.)
Claims 1, 6, 7, 9, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,132,817 in view of Amaral et al. (US 20060292640; reference A).
The ’817 patent claims a kit for detecting Alzheimer’s disease diagnostic biomarkers in a subject comprising (a) an ordered microarray comprising a substrate and autoantigens immobilized onto it, wherein the autoantigens include FRMD8 and LGALS1 plus a second group of autoantigens; (b) assay reagents for label-based detection of immunocomplexes formed by binding of immunoglobulins (autoantibodies) in a biological sample from the subject; and (c) package labeling. (Claim 1, in particular column 110, line 67, through column 111, line 1; and column 111, lines 2-3.) The ’817 patent’s kit is expressly claimed as being useful for detecting Alzheimer’s disease diagnostic biomarkers that bind autoantigens, i.e. antibodies. See also column 1, lines 50-56; column 2, lines 49-53; and column 29, lines 46-60 (expressly stated utility of claimed kit).
Regarding claim 6, the ’817 patent claims that the second group of autoantigens may comprise cDNA clone MGC:32654 IMAGE 4701898, complete cds. (Column 111, lines 20-21.)
Regarding claim 7, the ’817 patent claims that the second group of autoantigens may comprise cDNA clone MGC:27152 IMAGE:4691630, complete cds. (Column 11, lines 18-19.)
Regarding claim 9, the ’817 patent claims that the second group of autoantigens may comprise ANKHD1. (Column 111, lines 10-12.)
Regarding claim 10, the ’817 patent claims that the second group of autoantigens may comprise cDNA clone MGC:31944 IMAGE:4878869. (Column 111, lines 19-20.)
The ’817 patent does not claim a method of using the kit to determine the amount of Alzheimer’s disease diagnostic antibodies in a subject.
MPEP 804(II)(B)(1) instructs:
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1386-88, 95 U.S.P.Q.2d 1797, 1801-02 (Fed. Cir. 2010).
In this case, when examined claim 1 is properly construed, the scope of the claimed Alzheimer’s-disease-detection kit includes a method of using it to actually detect Alzheimer’s disease, based on the ’817 patent’s expressly stated utility of that kit.
Amaral teaches that labeled secondary antibodies are generally used in the art to detect autoantibodies in a sample that have bound to one or more antigens. Amaral teaches that secondary antibodies bind to immunoglobulins and can be labeled with any directly or indirectly detectable moiety, e.g. a fluorophore, an enzyme, a radioisotope, or a chemiluminescent moiety. (Paragraph 37.) Amaral teaches that the amount of autoantibody-antigen complex can be quantified using a digital imager, x-ray film developer, or automated plate reader using methods well known in the art. (Paragraph 38.)
It would have been obvious to use the ’817 patent’s kit in a method of determining the amount of Alzheimer’s disease diagnostic autoantibodies because the ’817 patent discloses that detection of these autoantibodies is the utility of the kit and Amaral teaches that labeling autoantibody-autoantigen complexes permits quantification of those complexes. See MPEP 804(II)(B)(1) (“it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context” (citing Sun Pharm.).)
Conclusion
Claims 1-35 are rejected.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP 1415.01.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,435,361 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lora E Barnhart Driscoll, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle, can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lora E Barnhart Driscoll/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/KSO/
Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 FERM domain-containing protein 8. This interpretation of claim 1 for this rejection does not negate applicant’s requirement to address the indefiniteness in claim 1 with respect to “CD8” being given as the abbreviation.
Prosecution Insights