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 .
DETAILED ACTION
Reissue: Non-Final Office Action
Status of the Claims
On 07/04/2023 US Patent 11,692,030 issued to Wallach et al. with claims 1-3. Claims 1-3 are currently pending and are the subject of this Office Action. Claims 1 and 3 are amended. This is the first Office Action on the merits of the claims in reissue Application No. 18/669,075.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP § 1415.01.
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 11,692,030 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
The references cited on the information disclosure statement(s) were considered and have been made of record to the extent that each was provided.
Consent of Assignee
The MPEP states that an officer (chief executive officer, president, vice-president, secretary, or treasurer) is presumed to have authority to sign on behalf of the organization. The signature of the chairman of the board of directors is acceptable, but not the signature of an individual director. Modifications of these basic titles are acceptable, such as vice-president for sales, executive vice-president, assistant treasurer, vice-chairman of the board of directors. In foreign countries, a person who holds the title "Manager" or "Director" is normally an officer and is presumed to have the authority to sign on behalf of the organization. A person having a title (administrator, general counsel) that does not clearly set forth that person as an officer of the assignee is not presumed to have authority to sign the submission on behalf of the assignee. The Office recommends that when a person with such a title is authorized to act on behalf of the assignee, the submission should clearly indicate that person's authority. See MPEP § 324(V).
The Consent of Assignee is signed by Greg Mario, identified by title only as "Mr". While Greg Mario is identified as the Chairman and CEO on the POA filed 05/20/2024, this POA was signed 05/15/2024, after the Consent of Assignee (signed 05/14/2024). Thus, there is no evidence of record that the person signing the Consent of Assignee was authorized to act on behalf of the assignee at the time the Consent of Assignee was signed. See MPEP § 324 (for applications filed before September 16, 2012) and § 325 (for applications filed on or after September 16, 2012). A proper consent of the assignee in compliance with 37 CFR 1.172 and 3.73 is required in reply to this Office action.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was Jun. 25, 2024.
Application Data Sheet
The Application Data Sheet filed 05/20/2024 lists underlying case 16/685,149 as a continuation in part (CIP) of PCT/US2018/032956. However, application 16/685,149 is a continuation (CON) of PCT/US2018/032956 as listed on the face of US Patent 11,692,030. Correction of this discrepancy is required.
Claim Objections
The claims are objected to for the following reasons:
A. The amended claim set filed 05/20/2024 is improper. The amendment does not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. Specifically, the claim set uses double brackets (e.g., see claims 1 and 3) to show deletions, instead of single brackets as required by 37 C.F.R. 1.173(d). While the improper amendment has been entered and considered, a supplemental paper correctly amending the reissue application is required. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
B. Claim 1 is objected to because of the following informalities: the number one in the term "HC1" at line 16 should be changed to the letter “l”, so it reads "HCl".
C. Claim 3 is objected to because of the following informalities: the word “of” is missing before “ICAM-1” at line 5.
Appropriate correction is required.
Defective Declaration/Oath
The reissue oath/declaration filed with this application is defective because it fails to properly identify the error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414.
Claims 1 and 3 are amended to replace the word “elevated” with “decreased”. This amendment clearly changes the scope of the claims. A claim is broader in scope than the original claims if it contains within its scope any conceivable product or process which would not have infringed the original patent. A claim is broadened if it is broader in any one respect even though it may be narrower in other respects. In this case, the amended claims of the reissue application would not have infringed the claims of the underlying '030 patent because the two claim sets require mutually exclusive conditions (i.e., IL-16 decreased relative to the control vs. IL-16 elevated relative to the control). Thus, the amendment broadens the claims of the reissue application relative to those of the '030 patent.
However, the reissue declaration does not indicate the original patent to be wholly or partially inoperative or invalid “by reason of the patentee claiming more or less than he had the right to claim in the patent” (which encompasses broadening), but rather “by reason of other errors”.
For broadening reissue applications, applicants are also required to identify a claim the application seeks to broaden. See MPEP § 1414(II), which states, in relevant part:
What is needed for the oath/declaration statement as to error is the identification of “at least one error” relied upon. For an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must also identify a claim that the application seeks to broaden. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.
The examiner suggests expressly pointing to claims 1 and 3 as claims intended to be broadened, and then specifically stating that these amended claims are broader than the patented claims since they change the claim scope to require determining that the concentration of IL-16 in the blood sample obtained from the patient is decreased relative to the control instead of elevated relative to the control.
CLAIM REJECTIONS - 35 USC § 251
Claims 1-3 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office Action.
Broadening Reissue
Claims 1-3 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 1-3 are broader in scope than the original patent claims.
The method of original claim 1 required determining that the concentration of IL-16 in the blood sample obtained from the patient is elevated relative to the control. In contrast, reissue claim 1 requires required determining that the concentration of IL-16 is decreased. A claim is broader in scope than the original claims if it contains within its scope any conceivable product or process which would not have infringed the original patent. In this case, the amended claims of the reissue application would not have infringed the claims of the underlying '030 patent because the two claim sets require mutually exclusive conditions (i.e., IL-16 decreased relative to the control vs. IL-16 elevated relative to the control). Thus, the amendment broadens the claims of the reissue application relative to those of the '030 patent.
(2) The broader aspect of the reissue of claims 1-3 is related to subject matter surrendered in the original prosecution.
During prosecution of application 16/685,149 that issued as US Patent 11,692,030, original claim 7 (which became patented claim 1) was amended on 08/04/2021 to recite “determining that the concentration of the one or more biomarkers in the blood sample obtained from the patient are elevated relative to the control” in response to rejections made in the non-final rejection dated 02/05/2021. Applicants argued that this limitation overcame the rejections under 35 U.S.C. 112(b) and 101, and that this limitation had an effect on the treatment step (bridging pgs. 7-8 of the 08/04/2021 response; see also page 4 of the supplemental reissue declaration). The list of recited biomarkers was eventually narrowed to only IL-16, and the “elevated” limitation was not only maintained, but adjusted to account for narrowing the claim to only IL-16 (amendments dated 10/20/2022 and 11/18/2022). The reissue claims seek to change a limitation that was relied upon in the prosecution of application 16/685,149, to gain the allowance of claims 1-3 in US Patent 11,692,030.
(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.
Applicants have not provided any evidence or explanation to show why the amended reissue claims have been narrowed to avoid the recapture rule.
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 Application 18/201,599
Claims 1-3 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 60, 61, 72, and 75-91 of copending Application 18/201,599. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '599 claims anticipates or renders obvious that of the instant claims. The difference between the two claim sets is that the '599 claims recite a computer readable storage medium of instructions for executing a method that includes the same measuring, comparing, and determining steps as the instant claims. As such it would have been prima facie obvious to one of ordinary skill in the art to have employed the computer readable storage medium of the '599 claims to carry out the instant method and treat a patient by means known in the art.
US Patent Application 18/538,669
Claims 1-2 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 80-85 of copending Application 18/538,669. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '669 claims anticipates or renders obvious that of the instant claims. The difference between the two claim sets is that the '669 claims recite a computer readable storage medium of instructions for executing a method that includes the same measuring, comparing, and determining steps as the instant claims. As such it would have been prima facie obvious to one of ordinary skill in the art to have employed the computer readable storage medium of the '669 claims to carry out the instant method and treat a patient by means known in the art.
US Patent 11,885,817
Claims 1-2 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 6-11 of US Patent 1,885,817. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '817 claims anticipates or renders obvious that of the instant claims. The difference between the two claim sets is that the '817 claims recite a Markush group of biomarkers, including IL-16 that are contacted with one or more antibodies (i.e., detection or capture antibodies). The '817 claims anticipate the instant claims.
Conclusion
Claims 1-3 are rejected. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
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 571-273-9900.
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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
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