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 .
Information Disclosure Statement
The information disclosure statements (IDS’) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because FIGS. 1, 3A and 3B include grayscale filles, gradients and soft shading with is not permitted under 37 CFR 1.84(m) because these images may not be easily reproducible. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The Abstract recites “having a least” and should recite “having at least”.
Paragraph [0028] recites “(e.g. compared to a control not have a condition)” and should recite “(e.g. compared to a control not having a condition)”
Paragraph [0050] recites “by-products and/or or other molecules” and should recite “by-products and/or other molecules”.
Paragraph [0135] recites “Samples can be immediately be analyzed immediately or frozen” and should recite “Samples can be immediately be analyzed or frozen”
Appropriate correction is required.
Claim Objections
Claims 1, 8 and 15 are objected to because of the following informalities:
Claim 1 recites “two-part” and Claim 8 recites “2-part”, one of which should be chosen for consistency.
Claim 15 recites “agent associate with one or more indicators…” and should recite “agent associated with one or more indicators…”
Appropriate correction is required.
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 1-8, 10-19 and 21-23 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.
The term “optimum delivery” in claim 1 is a relative term which renders the claim indefinite. The term “optimum delivery” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to claim that the line or drag material is capable of being deployed through the opening of the capsule when deployed in the GI tract.
Regarding Claim 1, the limitation “the line configured for optimal delivery” renders the claim indefinite, as the claim previously sets forth “a line or drag material”, thus, limiting “the line and drag” to the single limitation of the “line” makes it unclear if the drag material is also configured for optimal delivery, or what influence the drag has with respect to optimal delivery. For purposes of examination the indefinite limitation has been deemed to claim where the line or drag material is configured for optimal delivery.
Regarding Claim 1, the limitation “line or drag material” renders the claim indefinite, as it is unclear of the limitation of “material” is to be compounded with the line. For instance, does the claim limitation entail line OR drag material, or, line material OR drag material? For purposes of examination the indefinite limitation has been deemed to claim line material or drag material.
Regarding Claim 10, the limitation “the device according to claim 9” renders the claim indefinite, because Claim 9 has been cancelled. For purposes of examination the indefinite limitation has been deemed to depend from Claim 1.
Regarding Claim 10, the limitation “a center position of the window” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination the indefinite limitation has been deemed to claim the deployment opening. Furthermore, the limitation “an open end” renders the claim indefinite because it is unclear if such open end is the deployment opening as set forth in Claim 1. For purposes of examination the indefinite limitation has been deemed to claim that the device has a window that is capable of being a distance of 2.5 to 7.5 mm to a from from the deployment opening.
Regarding Claim 12, the limitation the 3-ply material can be “configured similarly or differentially configured” for sampling the GI tract of the subject renders the claim indefinite because it is unclear what standard is applied when determined what makes the 3-play material similarly or differentially configured for sampling. For purposes of examination the indefinite limitation has been deemed to claim each of the ply materials can be the same ply material or different ply materials together.
Regarding Claim 13, the limitation equal to or greater than 35 N to 40 N renders the claim indefinite because such range coupled with equal to or greater than doesn’t make sense as a single range condition. For purposes of examination the indefinite limitation has been deemed to claim either between 35 N and about 40 N and/or equal to or greater than about 35 N.
Regarding Claim 19, the limitation “wherein the unit is sterilized” renders the claim indefinite, because the limitation appears to be a process/method claim within an apparatus claim. For purposes of examination the indefinite limitation has been deemed to claim that the unit is capable of and/or configured to be sterilized.
Regarding Claim 22, the limitation “the adjustable line” lacks proper antecedent basis. For purposes of examination the indefinite limitation has been deemed to claim the line or drag as set forth in Claim 1.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-8, 10, 16-19 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5738110 A to Beal et al. (hereinafter, Beal).
Regarding Claim 1, Beal discloses a device for sampling from or delivery to a gastrointestinal tract of a subject comprising inter alia:
a two-part ingestible capsule (capsule 12, which is two parts, a base 20 and a cap 22, col. 4, lines 1-2), wherein the capsule comprises a line or drag material deployment opening (perforation 18) (col. 4, lines 35-36 “…string 24 passing through perforation 18…” indicating that perforation 18 is an opening);
a line or drag material (line 16, which is comprised of string 24 and sampling cloth 26, col. 4, lines 4-7) enclosed within an interior of the capsule (col. 4, lines 9-13), the line or drag material having a proximal segment (string 24) and a distal segment (cloth 26), wherein a distal end of the proximal segment is operably linked to a proximal end of the distal segment (distal end of cloth 26 is connected to the proximal end of string 24, FIG. 2);
a weighted component (drag material 14 and/or small metal ball 114) enclosed within an interior of the capsule (col. 4, lines 3-4 “The drag material 14 is placed in the nadir of base 20.”) (col. 7, lines 46-48 “…if the inner surface of the capsule 112 is coated. A small metal ball 114 may be incorporated into the coating at the base 120 of the capsule 112 to serve as a weight.”) away from the line or the drag material deployment opening (drag material 14 and/or small metal ball 114 are located “away from” line 16, because drag material 14 and metal ball 114 are located in the nadir of the base, at the opposite side from the location of the string 24 and cloth 26, as best seen in FIG. 1 and described at col. 4, lines 2-4);
the line configured for optimal delivery through the line or the drag material deployment opening of the capsule when deployed in the gastrointestinal tract of the subject (col. 5, lines 18-20 “While the capsule 12 descends through the esophagus and into the stomach, the line 16 plays out through the perforation 18 in the cap 22.”); and
the line or drag material comprising one capture agent capable of capturing from one or more agents in the gastrointestinal tract of the subject (the line or drag material comprises a capture agent being a cloth material 26 that is capable to collect blood in the stomach, col. 5, lines 1-12 and also capable to collect epithelial cells, col. 6, lines 32-34).
Regarding Claim 2, Beal discloses the device according to claim 1, wherein the proximal segment (string 24) is narrower than the distal segment (cloth 26) (col. 4, lines 16-20 “the sampling cloth 26 … two centimeters wide … the string 24 … nylon fibers…”) (FIG. 2 shows a narrower string 24 with respect to a wider cloth 26) and remains outside an esophagus of the subject (col. 1, lines 13-15 “…the patient holds a free end of the line before swallowing the capsule…”).
Regarding Claim 3, Beal discloses the device according to claim 2, wherein the distal segment (cloth 26) of the line is able to bind to at least one of proteins, polypeptides, chemicals, polynucleotides, microorganisms or by-products thereof, cells, liquid compositions, other agents or analyte located in the gastrointestinal tract (the line or drag material comprises a capture agent being a cloth 26 that is capable to collect blood in the stomach, col. 5, lines 1-12 and also capable to collect epithelial cells, col. 6, lines 32-34).
Regarding Claim 4, Beal discloses the device according to claim 1, wherein at least a portion of the proximal segment extends through the line deployment opening of the ingestible capsule (col. 4, lines 35-36 “…string 24 passing through perforation 18…” indicating that perforation 18 is an opening), and wherein the proximal segment outside the ingestible capsule is capable of being secured in or outside of a mouth of the subject (col. 1, lines 13-15 “…the patient holds a free end of the line before swallowing the capsule…”).
Regarding Claim 5, Beal discloses the device according claim 1, wherein the line or drag material comprises a distal segment comprising a drag material comprising absorbent fiber, mesh fiber or textured fiber (nylon, col. 4, lines 15-18).
Regarding Claim 6, Beal discloses the device according to any one of claim 5, wherein the drag material comprises nylon (nylon, col. 4, lines 15-18).
Regarding Claim 7, Beal discloses the device according claim 1, wherein the capsule is dissolvable (col. 4, lines 20-22 “The capsule 12 is preferably a gelatin pharmaceutical capsule that readily dissolves when subjected to stomach acid.”).
Regarding Claim 8, Beal discloses the device according to claim 1, wherein the 2-part ingestible capsule comprises a cap (cap 22) and a base (base 20) configured to operably mate so as to form the interior of the capsule (FIG. 1), and wherein the line comprises a pre-configured line for insertion into the interior of the capsule (col. 4, lines 9-13).
Regarding Claim 10, Beal discloses the device according to claim 9, wherein a center position of the window comprises about 2.5 to about 7.5 mm distance from a rim of an open end of the ingestible capsule base. The loop (col. 4, lines 13-15 “A loop 25 may be formed at the end of string 24…”) is a window that is capable of being manipulated by the user to be a distance of about 2.5 to 7.5 mm from a rim of an open end.
Regarding Claim 16, Beal discloses the device according to claim 1, wherein the proximal segment and distal segment comprise an adhesive compound for linking the proximal segment to the distal segment of the line (col. 4, lines 53-56 “After the sampling cloth 26 is produced, it is woven into the proximal segment 24 and secured by an appropriate glue. preferably silicone rubber glue or heat sealed together.”).
Regarding Claim 17, Beal discloses the device according to claim 1, wherein the weighted component further comprises an adhesive compound for associating the weighted component to the ingestible capsule (mineral oil and beeswax, col. 4, lines 63-67 and/or coating which incorporates metal ball 114 into the base, col. 7, lines 45-47).
Regarding Claim 18, Beal discloses the device according to claim 1, wherein a terminal proximal end of the proximal segment comprises a loop (col. 4, lines 13-15 “A loop 25 may be formed at the end of string 24…”).
Regarding Claim 19, Beal discloses the device according to claim 1, wherein the device comprising the ingestible capsule, the line or drag material and the weighted component comprise a unit (catheter 32) and wherein the unit is sterilized (catheter 32 is capable of being sterilized).
Regarding Claim 21, Beal discloses a kit comprising the device according to claim 1 (see rejection of Claim 1, above), and at least one container (catheter 32).
Regarding Claim 22, Beal discloses a method for analyzing the gastrointestinal tract of a subject comprising, deploying the device according to claim 1 into the gastrointestinal tract of the subject (col. 5, line 15 “…the capsule is swallowed.”); retrieving the adjustable line (col. 5, lines 24-26 “…the line 16 is pulled up from the stomach and removed completely from the mouth.”) and analyzing the distal segment of the adjustable line of the device for captured diagnostic agents or health indicators from the gastrointestinal tract of the subject (col. 6, lines 40-43 “The collected cells and mucoid material may be scraped off of the sampling cloth 26 and examined microscopically for the presence of red and white blood cells and various parasites.”).
Regarding Claim 23, Beal discloses the method according to claim 22, wherein the microbiota of the subject is analyzed (col. 6, lines 43-46 “The removed material may alternatively be placed in culture media favoring growth and identification of such bacteria as Salmonella typhi and Helicobacter pylori. Thus a culture-augmented immunoassay may be performed... “).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beal in view of WO 0115604 A1 to Marshall et al.
Beal discloses the device according to claim 1 including where the line or drag material is nylon (nylon, col. 4, lines 15-18). Beal does not expressly disclose where the line or drag material comprises a 3-ply material wherein each ply of the 3-ply material can be configured similarly or differentially configured for sampling the GI tract of a subject, where the distal segment of the line or drag material comprises a failure strength equal to or greater than 35 N to 40 N when pulled at about 40 mm/minute to about 60 mm/minute to failure. However, Marshall discloses an ingestible sampling device that includes a drag material (Abstract), and further teaches a 4-ply nylon drag material or 2 & 3 ply cotton (page 16, line 23). Table 4 of the instant application states under “4) Distal Yarn” that a 3-ply 100% drag material would have a failure strength of 52.0 +/- 3.9, therefore, the 4-ply nylon drag material would inherently have a failure strength equal or greater than 35 N to 40N. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the nylon of Beal to be the 4-ply material of Marshall, as Marshall teaches that the 4 ply material would have yielded urease activity well-over a standard control string (page 16, lines 19-25) and further states that the type of weave material is an important factor in the device for collection of microorganisms from gastric juices (col. 17, lines 25-28).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beal in view of US 20200352430 A1 to Furuta et al. (hereainfter, Furuta).
Beal discloses the device according to claim 3 except for expressly disclosing wherein the capture agents comprise antibody capture agent ([0015] “… the device further comprises a capture agent for one or more diagnostic indicators … capture agents include antibodies”) associated with IL-8, (paragraph [0021]), MBP, ECP, EPO, EDN, and many more (paragraph [0019]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the agent of Beal to include the antibody capture agents and various diagnostic indicators of Furuta, as Furuta teaches at paragraph [0017] that capture agents would have allowed for the capture of diagnostic indicators for the purpose of examination by a number of different techniques known in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791