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 .
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 Claims
US Patent 11,069,054 issued on 7/20/21 with claims 1-4. This reissue application was filed 7/19/23 amending claim 1, canceling claim 4, and adding claims 5-12. Claims 1-3 and 5-12 are pending and under examination.
In future claim listings, applicant is requested to use black font to improve readability (see pixelation of new claims 5-7, e.g.). Double spacing is also preferred.
Information Disclosure Statement
Applicants supplied an information disclosure statement on 1/6/25, but certain references do not comply with 37 CFR 1.98. Nonpatent literature (NPL) references 49, 50, 53, and 262 provide no identifying bibliographic information. NPL references 256 and 257 are incomplete. They have been lined through and not considered.
Reissue Oath/Declaration
The reissue oath/declaration filed with this application is defective for two reasons.
A. First, 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. The error-identification portion of the reissue declaration states in its entirety, “The patentee claimed less than he had the right to claim in claim 1 of the patent.” This error statement is insufficient. 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 generic statement provided by applicants does not particularly identify at least one error sufficient to support reissue.
B. Second, inventor Sussman has refused to execute the oath or declaration under 37 CFR 1.475. (See reissue declaration, page 6/8.) In his stead, CEO and inventor Alan Nelson has signed a substitute statement. (See reissue declaration, page 7/8.) This substitute statement is inadequate, however, because it does not acknowledge the consequences of willful false statements. See 37 CFR 1.63(g).
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 Objections
Claim 7 is objected to because it contains the word “a” before “normal cell feature measurements” at line 5.
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 7-12 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 7 refers at lines 5-6 to “the set of known unique dysplastic cells and plurality of known normal cells.” There is insufficient antecedent basis in claim 7 for this limitation. Claim 7 does not previously refer to such a set and plurality. Clarification is required. See MPEP 2173.05(e).
Similarly, claim 7 refers at line 22 to “the optical tomography system,” but claim 7 does not previously recite such a system. Clarification is required. See MPEP 2173.05(e).
Claims 8-12 depend from claim 7 and do not resolve the indefiniteness, so they must be also rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC §§ 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 and 5-12 are 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).
Claims 1 and 7 are each 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. Claims 1 and 7 both require that the patient with lung dysplasia has been identified by a particular method, but they do 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 claims 1 and 7 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.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Meyer et al. (2015, Cancer Cytopathology 123: 513-523; NPL reference 125 on 1/6/25 IDS) teaches a method of diagnosing early lung cancer (dysplasia) by enriching cells isolated from sputum, then imaging the enriched cells using 3D tomography, then automatically classifying the cells based on several steps and algorithms involving maintaining data within acceptable confidence bounds. (Pages 514-516 and 518.)
Nandakumar et al. (2011, Cytometry Part A 79A: 25-34; NPL reference 143 on 1/6/25 IDS) teaches using optical tomography to distinguish between normal esophageal cells and those from high-grade dysplasia but does not address lung tissue or diagnosing lung dysplasia. Nandakumar also does not compare classified dysplastic cell types and classified normal cell types with diagnostic truth to determine an accuracy value, then comparing that value to a predetermined performance bound, then adjusting dysplastic cell feature values. Nandakumar does not teach repeating the comparing/adjusting steps until the accuracy value falls within the predetermined performance bound.
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.
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:
/Kevin S Orwig/Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991