DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/28/26 has been entered.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 16, 44, 59-64, 66-68, 71-75, and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20200077992 A1) in view of Bhardwaj (research publication Barrett's Esophagus: Emerging Knowledge and Management Strategies).
For claim(s) 1, 16, 44, 59, 71-73, 75, and 77 Markowitz teaches
A method for collecting a biological sample in a patient, [entire disclosure – see at least abstract] the method comprising:
identifying a location within an esophagus of the patient associated with Squamous Cell Carcinoma (SCC) and/or Squamous Dysplasia (SD); [¶¶41-42]
positioning, at the identified location within the esophagus, a device provided with a collection portion having a first axial end portion and a second axial end portion; [¶¶41-42]
axially moving the second axial end portion, relative to the first axial end portion, from a collapsed position within the first axial end portion into an expanded position; [Fig. 2 to Fig. 1, ¶¶41-42]
and collecting the biological sample with the second axial end portion in the expanded position, within the esophagus. [¶42]
For claim(s) 1, 16, 44, 59, 71-73, 75, and 77 Although Markowitz generally contemplates biological sampling of the esophagus and at least some form of analysis in ¶42, Markowitz fails to teach identifying a specific location within the esophagus associated with SCC, SD, EAC, GD, GERD, and/or BE and analyzing a biomarker thereof.
Bhardwaj teaches a method for analyzing patient cell samples [abstract] including identifying a location within an esophagus associated with SCC, SD, GERD, EAC, GD, and BE and analyzing biomarkers thereof. [p. 2 l. col. ¶2 detailing biopsy of particular areas of esophagus for squamous epithelium (where SCC and/or SD would be present); entirety of disclosure is regarding BE, EAC, GERD, and GD — see esp. p. 4-6; p. 13 § 15 – future directions]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the method of Markowitz to incorporate the location specifying of sampling and subsequent analyses within the esophagus as taught by Bhardwaj in order to aid in more effectively diagnosing the subject to ensure proper treatment. As motivated by Bhardwaj p. 1-2.
For claim 60, Markowitz teaches The method of claim 59,
further comprising axially moving the second axial end portion into the first axial end portion from the expanded position into the collapsed position to protect the biological sample. [¶42]
For claim 61, Markowitz teaches The method of claim 59,
wherein the biological sample includes esophageal cells. [¶¶41-42]
For claim 62, Markowitz teaches The method of claim 59,
wherein the step of axially moving the second axial end portion from the collapsed position into the expanded position includes moving the second axial end portion from a concave shape to a convex shape. [Figs. 1-3]
For claim 63, Markowitz teaches The method of claim 59,
wherein the step of axially moving the second axial end portion from the expanded position into the collapsed position includes moving the second axial end portion from a convex shape to a concave shape. [Figs. 1-3]
For claim 64, Markowitz teaches The method of claim 59,
wherein the step of axially moving the second axial end portion from the expanded position into the collapsed position includes causing an outer surface of the second axial end portion facing radially outwardly when the second axial end portion is in the expanded position to face radially inwardly when the second axial end portion is in the collapsed position. [Figs. 1-3]
For claim 66, Markowitz teaches The method of claim 59,
further comprising providing the second axial end portion with a plurality of tissue collecting projections designed to capture the biological sample including esophageal cells. [Figs. 1-3]
For claim 67, Markowitz teaches The method of claim 59,
wherein the step of removing the device from the esophagus includes preventing the second axial end portion of the collection portion from engaging the esophagus at an area different from the location in the esophagus. [¶42]
For claim 68, Markowitz teaches The method of claim 59,
wherein the step of axially moving the second axial end portion from the collapsed position into the expanded position includes applying pressurized air to the second axial end portion and the step of axially moving the second axial end portion from the expanded position into the collapsed position includes applying a vacuum to the collection portion. [¶41]
For claim 74, Markowitz teaches The method of claim 1,
wherein, in the collecting step, the second axial end portion includes projections [40] designed for the collection of squamous cells.
Claim(s) 30 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Furuzawa (research publication: Achalasia—An Autoimmune Inflammatory Disease: A Cross-Sectional Study).
For claim(s) 30 and 76, Markowitz teaches A method for collecting a biological sample in a patient, the method comprising:
identifying a location within an esophagus; positioning, at the identified location within the esophagus, a device provided with a collection portion having a first axial end portion and a second axial end portion; axially moving the second axial end portion, relative to the first axial end portion, from a collapsed position within the first axial end portion into an expanded position; and collecting the biological sample with the second axial end portion in the expanded position, at the identified location within the esophagus. [Fig(s). 2 to Fig(s). 1 and ¶¶41-42]
For claim(s) 30 and 76, Although Markowitz generally contemplates biological sampling of the esophagus and at least some form of analysis in ¶42, Markowitz fails to teach identifying a specific location within the esophagus associated with HSV.
Furuzawa teaches a method of evaluating and sampling a subject [abstract] comprising identifying a specific location within an esophagus of a subject associated with HSV [abstract, p. 2 r. col.] as well as detecting HSV in the esophageal sample. [entire disclosure – see at least abstract]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the method of Markowitz to incorporate the HSV sampling location and HSV detection of Furuzawa in order to aid in assessing the subject’s esophagus for common esophageal disorders. As motivated by Furuzawa p. 1.
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
Claim(s) 1, 16, 44, 59-64, 66-68, 71-75, 77 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2, 4, 7, 11, 12, 13, 15, 16, 18, 21, 25-27, 29-32, 35, 39-41 of copending Application No. 17855530 in view of Bhardwaj.
The pending claim(s) are substantially anticipated by the copending claim(s) but for the claim language encompassing identifying a location of SCC, SD, EAC, GD, GERD, and/or BE. Bhardwaj teaches such features with clear motivation to combine as detailed in the § 103 rejection(s) above. As such, the pending claim(s) are obvious in scope over the copending claim(s).
Claim(s) 30, 76 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2, 4, 7, 11, 12, 13, 15, 16, 18, 21, 25-27, 29-32, 35, 39-41 of copending Application No. 17855530 in view of Furuzawa.
The pending claim(s) are substantially anticipated by the copending claim(s) but for the claim language encompassing identifying a specific location of HSV. Furuzawa teaches such features with clear motivation to combine as detailed in the § 103 rejection(s) above. As such, the pending claim(s) are obvious in scope over the copending claim(s).
The above are provisional nonstatutory double patenting rejections.
Response to Arguments
Applicant’s arguments with respect to the prior art have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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