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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/24/26 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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1, 2, 4, 7, 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20200077992 A1) in view of Srinagesh (research publication: Biomarkers in acute graft-versus-host disease).
For claim(s) 1, 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 a gastrointestinal tract; positioning, at the identified location, 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. [¶¶41-42 Fig(s). 2 then Fig(s). 1]
For claim(s) 1 and 13, 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 GVHD location within the GI tract.
Srinagesh Teaches an esophageal method of identifying a GVHD sampling location and detecting GVHD. [abstract, introduction, The Map and GI GVHD biology]
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 esophageal GVHD location sampling and detection of Srinagesh in order to determine whether GVHD is present in the esophageal pathology. As motivated by Markowitz ¶3, Srinagesh abstract, introduction, and GI GVHD biology.
For claim 2, Markowitz teaches the method of claim 1, 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 4, Markowitz teaches the method of claim 1,
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, or 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. [Fig(s). 1-3]
For claim 7, Markowitz teaches the method of claim 1,
wherein the step of positioning the collection portion of the device at the identified location includes swallowing the collection portion. [¶41]
For claim 11, Markowitz teaches the method of claim 1, further comprising performing at least one of pathological analysis, diagnostic analysis, and cell analysis on the biological sample including esophageal cells. [washing and collecting at end of ¶42 constitute(s), under BRI, at least some form of analysis]
For claim 12, Markowitz teaches the method of claim 1, further comprising removing the device from the gastrointestinal tract of the patient. [¶42]
Claim(s) 15, 16, 18, 21, 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Telakis (research publication: Debilitating Chronic Diarrhea Caused by Generalized Gastrointestinal Cytomegalovirus Infection in an Immunocompetent Adult).
For claim(s) 15, 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 a gastrointestinal tract; positioning, at the identified location, 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. [¶¶41-42 Fig(s). 2 then Fig(s). 1]
For claim(s) 15 and 27, 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 CMV location within the esophagus.
Telakis teaches an esophageal method of detecting CMV. [abstract, introduction, throughout p. 2]
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 esophageal CMV detection of Telakis in order to determine whether additional treatment and/or steps are necessary to ensure the health of the patient. As motivated by Telakis abstract, discussion.
For claim 16, Markowitz teaches the method of claim 15, 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 18, Markowitz teaches the method of claim 15,
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, or 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. [Fig(s). 1-3]
For claim 21, Markowitz teaches the method of claim 15,
wherein the step of positioning the collection portion of the device at the identified location includes swallowing the collection portion. [¶41]
For claim 25, Markowitz teaches the method of claim 15, further comprising performing at least one of pathological analysis, diagnostic analysis, and cell analysis on the biological sample including esophageal cells. [washing and collecting at end of ¶42 constitute(s), under BRI, at least some form of analysis]
For claim 26, Markowitz teaches the method of claim 15, further comprising removing the device from the esophagus of the patient. [¶42]
Claim(s) 29-32, 35, 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Pease (US 20150057517 A1).
For claim(s) 29, 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 a gastrointestinal tract; positioning, at the identified location, 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. [¶¶41-42 Fig(s). 2 then Fig(s). 1]
For claim(s) 29 and 41, Although Markowitz generally contemplates biological sampling of the esophagus and at least some form of analysis in ¶42, Markowitz fails to teach detecting Candidiasis.
Pease teaches an esophageal method of detecting Candidiasis. [¶154]
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 esophageal Candidiasis detection of Pease in order to determine whether Candidiasis is present in the esophageal pathology. As motivated by Markowitz ¶3, Pease ¶154.
For claim(s) 31, Markowitz teaches
wherein the biological sample includes buccal cells, squamous cells, vaginal cells, and/or Candida cells. [¶42]
For claim(s) 35, Markowitz teaches
wherein the step of positioning the collection portion of the device into the gastrointestinal tract includes swallowing the collection portion. [¶41]
For claim(s) 39, Markowitz teaches
further comprising performing at least one of pathological analysis, diagnostic analysis, and cell analysis on the biological
sample including esophageal cells. [washing and collecting at end of ¶42 constitute(s), under BRI, at least some form of analysis]
For claim(s) 40, Markowitz teaches
further comprising removing the device from the patient. [¶42]
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, 2, 4, 7, 11-13 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 30, 44, 59-64, 66-68, and 71-77 of copending Application No. 17855515 in view of Srinagesh.
The pending claim(s) are substantially anticipated by the copending claim(s) but for the claim language encompassing identifying a specific location of GVHD. Srinagesh 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) 15, 16, 18, 21, and 25-27 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 30, 44, 59-64, 66-68, and 71-77 of copending Application No. 17855515 in view of Telakis.
The pending claim(s) are substantially anticipated by the copending claim(s) but for the claim language encompassing identifying a specific location of CMV. Telakis 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) 29-32, 35, and 39-41 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 30, 44, 59-64, 66-68, and 71-77 of copending Application No. 17855515 in view of Pease.
The pending claim(s) are substantially anticipated by the copending claim(s) but for the claim laguage encompassing identifying a specific location of Candidiasis. Pease 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
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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