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 .
Status of Claims
Applicant’s reply of 6/24/26 amending claims 1 and 7 is acknowledged. Claims 1-3 and 5-12 are pending.
Reissue Oath/Declaration
The reissue oath/declaration filed 6/24/26 is defective for two reasons.
A. The reissue declaration fails to sufficiently identify at least one error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414. First, there appears to be a typographical error referring to “a gate driver” at line 2. Second, the declaration is inaccurate as to what was claimed in US Patent 11,069,054. Patent claim 1 is not drawn to “a method of treating a malignancy in a subject,” it recites “a method of training and using an automated dysplastic cell algorithmic classifier directed to treating a malignancy in a subject.” It also recites administering any “immunomodulating agent.” Reissue claim 1, however, recites “a method of treating lung dysplasia” and limits the administered agent to iloprost. The 6/24/26 declaration states that the reissue claims are broader than the patent claims, but even if the declaration were accurate as to the ’054 claims, it is not clear how “lung dysplasia” is broader than “malignancy” since the latter does not specify any particular organ or tissue. Any error in the claims must be identified by reference to the specific claim(s) and the specific claim language wherein lies the error. See MPEP 1414(II)(C). The 6/24/26 declaration does not accurately identify the erroneous claim language from the patent claims and therefore cannot support reissue.
B. Inventor Sussman has not signed the oath or declaration under 37 CFR 1.475. (See reissue declaration, page 7/9.) In his stead, CEO and inventor Alan Nelson has signed the form PTO/AIA /06. (See reissue declaration, page 8/9.) This is improper. See 37 CFR 1.4(d)(1)(i) (requiring a signature “personally signed . . . by that person”).
Upon reconsideration of the 12/11/23 substitute statement, the examiner notes that the form PTO/AIA /07 indeed acknowledges the consequences of willful false statements. The reissue oath/declaration submitted in response to this Office action should use that form should inventor Sussman continue to refuse to sign. Any inconvenience is regretted.
Rejections—35 U.S.C. § 251
Claims 1-3 and 5-12 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.
Claim Rejections - 35 U.S.C. §§ 102 and 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 remain rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Keith et al. (2011, Cancer Prevention and Research 4: 793-802 (NPL reference 99 on 1/6/25 IDS).
Claim 1 is drawn to methods of treating a patient with lung dysplasia comprising administering iloprost at a dose of about 50-150[Symbol font/0x6D]g BID to the patient. Claim 1 requires that the patient with lung dysplasia has been identified by a particular method, but it does not recite the method’s components as active steps—rather, they are drafted as a product-by-process limitation describing the manner in which the treated patient is identified.
MPEP 2113(I) instructs, “If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Here, the manner in which a patient is identified for iloprost treatment does not appear to imply any particular structure within that patient. Put another way, there is no evidence on this record that patients diagnosed with lung dysplasia using the steps of claim 1 are structurally different from patients diagnosed with lung dysplasia using standard histological examination. A patient either has lung dysplasia or does not.
Keith teaches treating patients with lung dysplasia by administering iloprost clathrate (50[Symbol font/0x6D]g per tablet) BID, escalating to three tablets BID for a total of 150[Symbol font/0x6D]g. (Page 794, column 2.) Keith teaches that the patients were identified using histological grading of hematoxylin/eosin-stained fixed endochondrial biopsies. (Page 794, column 2.)
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product—in this case, the diagnosed patient. MPEP 2113(II). The C.C.P.A. has advised, “We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable.” MPEP 2113(III) (quoting In re Brown, 459 F.2d 531, 535 (C.C.P.A. 1972)).
As a practical matter, the Patent Office is not equipped to carry out diagnoses by the myriad of processes put before it and then obtain identified patients and make physical comparisons therewith. See MPEP 2113(III). Evidence that the manner of diagnosis affects the structure of the patient would be probative.
Response to Arguments
Applicant alleges that the examiner did not explain why the claims are product-by-process claims. (Reply at 8.) As discussed above and previously, however, “there is no evidence on this record that patients diagnosed with lung dysplasia using the steps of claim 1 are structurally different from patients diagnosed with lung dysplasia using standard histological examination.” (Emphasis added; see MPEP 2113 (discussing the implications of product-by-process limitations on the structure of the product). Applicant is correct that the patient is the relevant product (i.e., a composition of matter).
Applicant alleges that “the information regarding the patient is the product of such a method” and that information is not a “product” in any event. (Reply at 8.) The method, however, includes a step of “selecting a patient identified by” certain steps. It is the patient, not the information, that is selected and treated with iloprost.
Applicant alleges that claim 1 has been amended to recite “identifying the patient as having lung dysplasia.” (Reply at 8.) Claim 1 has not been so amended. There is no positively recited step of “identifying”; compare claim 7.
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. 11,069,054 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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:
/LEE E SANDERSON/ Reexamination Specialist, Art Unit 3991
/Patricia L Engle/
SPRS, Art Unit 3991
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