Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Reissue: Non-Final Office Action
Status of the Claims
On 3/16/2021 U.S. Patent 10,948,487 issued to Mehra et al. with claims 1-26. Claims 1-49 are currently pending and are the subject of this Office Action. Claims 27-49 are newly presented in the instant reissue application. This is the first Office Action on the merits of the claims in reissue Application No. 18/185,343.
Ongoing Duty To Disclose
Applicant(s) is/are 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. 10,948,487 is or was involved. These proceedings would include any trial at 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.
Information Disclosure Statement
References lined-through on the information disclosure statement(s) were not considered because they were not provided. 37 CFR 1.98(a)(2) requires a legible copy of each foreign patent and each publication or that portion which caused it to be listed, other than U.S. patents and U.S. patent application publications unless required by the Office.
None of the references listed on the IDS(s) in the application(s) to which this application claims benefit will appear on the face of a patent issuing from this application unless they are properly listed on an IDS in this application. See MPEP § 1406.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was Apr. 11, 2023.
Claim Objections
Claim 9 is objected to because the claim does not end with a period. MPEP § 608.01(m) states that each claim begins with a capital letter and ends with a period. Appropriate correction is required.
Specification Objections
The amendment to the specification filed 3/16/23 is objected to because it does not comply with 37 CFR 1.173(d). Specifically, the amendment uses strikethroughs to show deleted matter. Matter to be omitted by reissue must be enclosed in single brackets. The 3/16/23 amendment has not been entered. A replacement amendment to the specification should be filed with the proper markings to address this issue.
Recapture
Claims 27–49 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
A broadening aspect is present in the reissue application which was not present in the patent under reissue. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984).
In accordance with MPEP 1412.02 (and case law cited therein) we apply the recapture rule as a three-step process:
(1) Determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims.
(2) Determine whether the broader aspects of the reissue claims related to subject matter surrendered in the original prosecution; and
(3) Determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In the instant case,
(1) Reissue claims 27–49 are broader in scope than the original patent claims.
Original (patented) claim 1 required a population of peptides comprising two or more different peptides. Similarly, independent claims 17 and 26 each require a population of peptides comprising at least three peptides. Claim 27, from which all of new claims 28-49 ultimately depend, only requires a single peptide (SEQ ID NO: 72 from element (i) of claims 1, 17, and 26). Thus, all of claims 27-49 are broader than the patented claims.
(2) The broader aspect of the reissue of claims 27–49 is related to subject matter surrendered in the original prosecution.
During prosecution of application 16/552,381 that issued as 10,948,487, original claims 1-5, 7-14, 16, 17, and 26 were rejected under 35 U.S.C. second paragraph as indefinite for requiring only one peptide while reciting a population of peptides (see p. 3 of the 7/17/20 Office Action. In order to overcome the rejection of claims 1-5, 7-14, 16, 17, and 26 under 35 USC 112, second paragraph, applicants amended claim 1 to require two or more different peptides. Applicants argued that “as long as there is a second peptide in the population, the preamble is met” (see pgs. 10-11 of the response dated 10/16/20). Thus, the new reissue claims seek to recapture a broader limitation (only one peptide) that applicants surrendered in the prosecution of application 16/552,381, to gain the allowance of claims 1-26.
(3) There is no evidence of record that the reissue claims were materially narrowed in other respects so that the claims may not have been enlarged, and hence avoid the recapture rule. While claim 27 omits embodiments in which the peptide may be a fragment comprising at least 20 contiguous amino acids of SEQ ID NO:72, this omission only limits the reissue claims to a single embodiment within the originally presented claims that embraced a single peptide, and is therefore unrelated to the surrendered subject matter.
Claim Rejections - 35 USC § 112(b) or (pre-AIA ) 35 USC § 112 (2nd Par.)
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.
Claim 36 is 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 pre-AIA the applicant regards as the invention.
A. Claim 1 is indefinite in the recitation "X24 in SEQ ID NOs 72 and" in element (ii) of the claim. Specifically, element (ii) of claim 1 is concerned with SEQ ID NO: 3, and the reference to SEQ ID NO: 72 appears to be unnecessary and/or misplaced. The meaning of this term/phrase is unclear.
B. Claim 36 is indefinite because it is unclear if "the ligand" recited in claim 35, from which claim 36 depends, is one of the options recited in claim 36 or whether the Markush group recited in claim 36 is in addition to "the ligand" recited in claim 35. If the Markush group recited in claim 36 is intended to represent options for "the ligand" recited in claim 35, claim 36 should be amended to refer to "wherein said ligand is" or "wherein the ligand is" for clarity.
Priority
The earliest possible priority date of the instant case is Oct. 11, 2012, as the instant application is a reissue of 16/552,381, which is a CON of 15/608,560, which is a CON of 14/842,440, which is a DIV of 14/252,690, which is a CON of 14/052,296, which claims priority to provisional 61/712,578 (filed Oct. 11, 2012).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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.
Claims 1-13, 15, 16, 18-22, 24, and 25 are rejected under 35 U.S.C. 102(b) as being anticipated by MEHRA (US 2011/0124125; Pub. May 26, 2011; on IDS).
Priority and claim Interpretation: Mehra was published on May 26, 2011, which is more than one year before the earliest possible priority date of the instant case (Oct. 11, 2012). As such, Mehra is prior art under pre-AIA 102(b).
The patented claims recite a population of isolated peptides comprising two or more different peptides that each comprise one or more peptides selected from the options recited in elements (i)-(iii) or a combination of peptides from elements (i)-(iii) as recited in element (iv) of patented claim 1. Thus, the patented population of peptides is met by any one peptide from elements (i)-(iii) of patented claim 1 in combination with ANY additional peptide (which additional peptide is NOT required to be a peptide recited in elements (i)-(iii) of patented claim 1).
Mehra discloses peptide compositions useful for detection of antibodies that bind Ehrlichia antigens (title; abstract, [0006]). Mehra teaches peptides including (but not limited to) SEQ ID NOs: 7-22 ([0047]), SEQ ID NOs: 27-42 ([0048]), SEQ ID NOs: 43-58 ([0049]), SEQ ID NOs: 60-75 ([0052]); and SEQ ID NOs: 76-91 ([0053]). Many of these peptides anticipate the embodiment of '487 claim 1 in which the population contains fragments of peptides comprising at least 20 contiguous amino acids of SEQ ID NOs: 72, 3, or 71.
For example, SEQ ID NO: 7 of Mehra matches instant SEQ ID NOs: 72 and 3 from residues 1-26, when in instant SEQ ID NOs: 72 and 3, X2 = A; X5 = E; X8 = T; X10 = T; X11 = G; X12 = L; X13 = Y; X18 = D; X20 = D; X22 = S; X23 = A; X24 = A ; X25 = T; X26 = S. Similarly, SEQ ID NO: 27 of Mehra matches instant SEQ ID NOs: 72 and 3 from residues 1-26, when the values in instant SEQ ID NO: 72 and 3 are as above except where X26 = N. Similarly, SEQ ID NO: 43 of Mehra matches instant SEQ ID NOs: 72 and 3 from residues 1-26, when the values in instant SEQ ID NO: 72 and 3 are as above except where X26 = K. These peptides meet elements (i) and (ii) of claim 1.
Likewise, SEQ ID NO: 76 of Mehra matches instant SEQ ID NO: 71 from residues 2-38 (based on the numbering of instant SEQ ID NO: 71), when in instant SEQ ID NO: 71, X7 = K; X12 = K; X17 = E; X24 = K; X26 = E. This peptide meets element (iii) of claim 1.
Due to the large number of sequences both disclosed by Mehra and encompassed by the variables in the instant claims, the sequences (e.g., SEQ ID NOs: 7, 27, 43, and 76 of Mehra) pointed out here are not intended to represent a comprehensive list of every sequence disclosed by Mehra that reads on the instant claims. However, at least these sequences (and many others disclosed by Mehra) meet the limitation of a "fragment thereof comprising at least 20 contiguous amino acids of" SEQ ID NOs: 72, 3, and 71. Note that the '487 patent teaches that "a fragment of a peptide sequence described herein can further comprise an additional N-terminal peptide sequence, an additional C-terminal peptide sequence, or a combination thereof" (col. 20, line 65 to col. 21, line 1). Thus, any peptide containing at least 20 contiguous amino acids from one of the options of the '487 claims meets the limitation of a fragment thereof, even if it also comprises other N- or C-terminal amino acids, as is the case with the sequences disclosed by Mehra.
Regarding the limitation in '487 claim 1 of a population of peptides comprising two or more different peptides, Mehra teaches (and claims) a mixture of isolated peptides comprising two or more peptides of the invention ([0015], [0030]; claims 16-17).
Regarding claims 2-4, Mehra teaches peptides that meet elements (i), (ii), and (iii) of claim 1 (e.g., SEQ ID NOs: 7, 27, 43, and 76), which qualify as peptide fragments of claim 1 as discussed above. While claims 2-4 further limit variables of full-length SEQ ID NO: 72 (relative to the variables of claim 1), they do not actually require that full-length SEQ ID NO: 72 is actually selected. In other words, claims 2-4 still encompass the peptide fragments embraced by claim 1, while reciting a more limited version of SEQ ID NO: 72 if that alternative were to be selected. Thus, the peptide fragments that meet elements (i), (ii), and (iii) of claim 1 (e.g., SEQ ID NOs: 7, 27, 43, and 76), meet the limitations of claims 2-4 as currently drafted.
Regarding claim 5, Mehra teaches a mixture of three, four, or more different peptides ([0015]; claim 17).
Regarding claims 6-7 and 11-13, Mehra teaches conjugation of the peptides to a ligand (such as biotin or bovine serum albumin) via a terminal cysteine linker ([0013], [0016], [0075]-[0076], [0081], [0118]; claims 18-19).
Regarding claim 8, the sequences of Mehra referenced above comprise a minimum of 26 contiguous amino acids of SEQ ID NOs: 72, 3, or 71 as discussed above.
Regarding claims 9-10, Mehra teaches peptides of the invention further comprise an additional N- or C- terminal peptide sequence. The additional peptide sequence can comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more amino acids and can be either a native or non-native sequence, such as a non-OMP-1 Ehrlichia antigen ([0012], [0060], [0063]; claims 6-7).
Regarding claims 15-16, Mehra teaches the peptides attached or immobilized on a solid support, including beads, a flow path in a rotor, wells in microtiter plates, etc. ([0014], [0021], [0025], [0080], [0083]; claims 13, 21, 24, 25).
Regarding claim 18, Mehra discloses peptide compositions useful for detection of antibodies that bind Ehrlichia antigens (title; abstract, [0006]). Mehra teaches methods for detecting in a sample an antibody to an epitope of an Ehrlichia antigen, the methods comprising contacting a sample with a peptide of the invention, and detecting formation of an antibody-peptide complex comprising said peptide, wherein formation of said complex is indicative of the presence of an antibody to an epitope of a Ehrlichia antigen in said sample. The methods comprise contacting the sample with a mixture of two, three, four, or more different peptides of the invention ([0020]; claim 22).
Regarding claim 19, Mehra teaches in certain embodiments, the Ehrlichia antigen is from an infectious Ehrlichia species, such as Ehrlichia canis or Ehrlichia chaffeensis. ([0020]; claim 23).
Regarding claim 20, Mehra teaches detection comprising performing an ELISA assay, a lateral flow immunoassay, an agglutination assay, or using an analytical rotor ([0022]).
Regarding claim 21, Mehra teaches using a sample from a human or canine (claim 27).
Regarding claim 22, Mehra teaches the sample is from blood, serum, cerebral spinal fluid, urine, or saliva (claim 28).
Regarding claim 24, Mehra teaches a method for diagnosing monocytic ehrlichiosis in a subject, the method comprising: contacting a sample from the subject with an isolated peptide of claim 1; and detecting formation of an antibody-peptide complex comprising said peptide, wherein formation of the complex is indicative the subject having monocytic ehrlichiosis (claim 30).
Regarding claim 25, Mehra teaches a kit comprising one or more peptides and a labeling reagent capable of binding to an antibody that recognizes an epitope of the one or more peptides (claim 31).
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 14, 17, 23, and 26 are rejected under 35 U.S.C. 103(a) as being unpatentable over MEHRA (US 2011/0124125; Pub. May 26, 2011; on IDS).
The teachings of Mehra are presented supra, and are incorporated herein.
Regarding claim 14, Mehra teaches (and claims) a mixture of isolated peptides comprising three or more different isolated peptides of the invention ([0015], [0030]; claims 16-21). Mehra further teaches peptides that meet the limitations of each of elements (i), (ii), and (iii) of claim 1. Additionally, Mehra teaches conjugation of the peptides to a carrier protein such as bovine serum albumin) via a terminal cysteine linker ([0013], [0016], [0075]-[0077], [0118]). Although Mehra does not explicitly teach the combination of three specific peptides (of instant claim 1), each conjugated to bovine serum albumin is disclosed with sufficient specificity to be anticipatory, such a combination is within Mehra's teachings, and is thus obvious based on Mehra.
Similarly, regarding claim 17, Mehra teaches (and claims) a mixture of isolated peptides comprising three or more different isolated peptides of the invention ([0015], [0030]; claims 16-21). Mehra further teaches peptides that meet the limitations of each of elements (i), (ii), and (iii) of claim 17. Although Mehra does not explicitly teach the combination of three specific peptides (of instant claim 17) with sufficient specificity to be anticipatory, such a combination is within Mehra's teachings, and is thus obvious based on Mehra.
Regarding claim 23, Mehra teaches contacting the sample with two or more isolated peptides of the invention (claim 29). A skilled artisan would recognize that detection of multiple antibody complexes would indicate the presence of multiple different Ehrlichia antigens, and would indicate the presence of different Ehrlichia species if the peptides used were from different Ehrlichia species.
Regarding claim 26, Mehra teaches (and claims) a mixture of isolated peptides comprising three or more different isolated peptides of the invention ([0015], [0030]; claims 16-21). Mehra further teaches peptides that meet the limitations of each of elements (i), (ii), and (iii) of claim 1 (and claim 26). Mehra teaches kits comprising one or more isolated peptides ([0028], [0133]; claim 31). Although Mehra does not explicitly teach the combination of three specific peptides (of instant claim 26) with sufficient specificity to be anticipatory, such a combination is within Mehra's teachings, and is thus obvious based on Mehra.
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 obviousness-type 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); and 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
US Patent 8,828,675
Claims 1, 4, 5, 8, 11-23, and 25 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-22 of US Patent 8,828,675. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '675 claims anticipates or renders obvious that of the instant claims. '675 claim 1 recites a mixture of isolated peptides, wherein each isolated peptide comprises the sequence of SEQ ID NO: 59. SEQ ID NO: 59 of '675 matches instant SEQ ID NO: 71, when X5 = E; X6 = E, X11 = R; X16 = L; X18 = K; X19 = Q; X20 = Y; X25 = I; X27 = E; X29 = Q; X31 = Q; and X33 = K. Thus, the mixture of peptides recited in '675 claim 1 anticipates instant claim 1.
Regarding instant claim 11, '675 claim 3 recites biotinylation.
Regarding instant claims 12-14, '675 claim 4 recites conjugation to avidin, streptavidin, neurtravidin, or serum albumin.
Regarding instant claims 15-16, '675 claims 7-8 recite immobilization of the peptides on solid supports, such as beads, a lateral flow device, etc.
Regarding instant claims 18-20, '675 claims 5-9 recite the same method, as well as immobilization of the peptides on solid supports, such as beads, a lateral flow device, etc.
Regarding instant claim 21, '675 claim 10 recites a human, canine, or feline subject.
Regarding instant claim 22, '675 claim 11 recites that the sample is blood, serum, cerebral spinal fluid, urine, or saliva.
Regarding instant claim 25, '675 claim 12 recites a kit comprising a mixture of peptides and a labeling reagent capable of binding to an antibody that recognizes an epitope of one or more isolated peptides in the mixture.
US Patent 9,470,682
Claims 1, 4, 5-8, 11, 15-23, and 25 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-26 of US Patent 9,470,682. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '682 claims anticipates or renders obvious that of the instant claims. '682 claim 1 recites a mixture of isolated peptides comprising three or more different peptides, wherein each isolated peptide comprises the sequence of SEQ ID NO: 97. SEQ ID NO: 97 of '682 matches instant SEQ ID NO: 71, from positions 1-38. Thus, the mixture of peptides recited in '682 claim 1 anticipates instant claim 1.
Regarding instant claims 6-7, '682 claim 12 recites conjugation via a cysteine residue.
Regarding instant claim 11, '682 claim 11 recites biotinylation.
Regarding instant claims 15-16, '682 claims 14-15 recite immobilization of the peptides on solid supports, such as beads, a lateral flow device, etc.
Regarding instant claims 18-20, '682 claims 13-16 recite the same method, as well as immobilization of the peptides on solid supports, such as beads, a lateral flow device, etc.
Regarding instant claim 21, '682 claim 17 recites a human or canine subject.
Regarding instant claim 22, '682 claim 18 recites that the sample is blood, serum, cerebral spinal fluid, urine, or saliva.
Regarding instant claim 25, '682 claims 19-26 recite a kit comprising a mixture of peptides and a device capable of detecting formation of an antibody-peptide complex that recognizes an epitope of one or more isolated peptides in the mixture.
Conclusion
Claims 1-49 are rejected. No claims are currently allowable.
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/Kevin S Orwig/
Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991