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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 6, 2026 has been entered. Claims 1-5 and 7-21 are pending in the application with claims 9-14 being withdrawn from further consideration. The previous rejections of claims under 35 U.S.C. § 112(b) and 35 U.S.C. § 101 are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this office action.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, the phrase “configured to be in contact the affected part” should read - - configured to be in contact with the affected part - -.
Appropriate correction is required.
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.
Claims 1-3, 15-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cobain et al. (U.S. Patent Application Publication No. 20110179887; hereinafter “Cobian”).
Regarding claim 1, Cobian disclose a virus removal device (sample acquisition device (160) is capable of removing a virus, such as by abrasion; Fig. 12; para. [0029]) comprising:
a drive source (motor; para. [0097]) that generates power;
a contact part (14) configured to contact an affected part around an uterine orifice in a cervix or a vagina of a patient, the contact part having a surface geometry configured to apply an abrasive force to abrasively remove tissue of the patient (e.g., the projections and recesses form a regular geometrical arrangement over the outer area of body (14); Fig. 1; para. [0065]);
a power transmission part (12) that transmits the power to the contact part;
an operation part (164) that operates a position of the contact part; and
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a contact surface (outer part of body (14)) configured to be in contact with the affected part in the contact part, wherein
the contact surface has projections and recesses (annotated Fig. 2A below), and
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the projections or the recesses are formed in a lattice shape on the contact surface (e.g., the projections and recesses form a regular geometrical arrangement over the outer area of body (14); Fig. 1; para. [0065]), and
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the contact part is operated by the operation part while being driven by the drive source (paras. [0094]-[0099]) to abrasively remove the tissue containing human papillomaviruses in the tissue to treat or prevent cervical cancer (sample acquisition device (160) is capable of treating or preventing cervical cancer to scrape tissue of the affected part, thereby removing human papillomaviruses in the tissue, such as by abrading tissue to remove material; Fig. 12; para. [0029]).
Regarding claim 2, Cobian discloses wherein
the power transmission part has a long drive shaft (12) driven by the drive source (para. [0094]), and
the contact part rotates with rotation of the drive shaft (para. [0094]).
Regarding claim 3, Cobian discloses wherein the contact part is configured to be rotatable in both directions of forward rotation and reverse rotation (para. [0094]).
Regarding claim 15, Cobian discloses wherein the contact part is configured to be replaceable (para. [0031]).
Regarding claim 16, Cobian discloses wherein the contact part is made of a soft material (para. [0032]).
Regarding claim 18, Cobian discloses wherein the operation part is formed integrally with the power transmission part (Fig. 12), and has a grip portion to be gripped by a user (Fig. 12; paras. [0094]-[0099]).\
Regarding claim 19, Cobian discloses wherein the drive source is disposed integrally with the operation part (para. [0097]).
Regarding claim 20, Cobian discloses the device comprising:
a drive control unit (microprocessor; para. [0097]-[0098]) that controls driving of the drive source,
wherein the drive control unit controls driving of the drive source on the basis of an instruction from an operator (para. [0097]-[0098]).
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Cobian in view of Stenkvist (U.S. Patent No. 4448205).
Regarding claim 4, Cobian discloses the invention substantially as claimed, except for the contact part being formed in a conical shape. However, Cobian teaches that body (14) of the tissue collection device may define different shapes (para. [0054]).
Stenkvist, a reference in the gynecologic instrument field of endeavor, teaches shaping the contact part of a tissue collection device to be formed in a conical shape (Fig. 1) to facilitate positioning along the cervix to collect a tissue sample (col. 2, ll. 24-50).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the device of Cobian such that the contact part is formed in a conical shape, in view of Stenkvist, in order to facilitate collecting a tissue sample from a patient’s cervix.
Regarding claim 5, Cobian discloses the invention substantially as claimed, except for the contact part having a central portion being formed in a conical shape and a peripheral portion in a dish shape. However, Cobian teaches that body (14) of the tissue collection device may define different shapes (para. [0054]).
Stenkvist teaches shaping the contact part of a tissue collection device such that a central portion is formed in a conical shape, and a peripheral portion continuously disposed from the central portion is curved in a dish shape (Fig. 1) to facilitate positioning along the cervix to collect a tissue sample (col. 2, ll. 24-50).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the device of Cobian such that the contact part is formed in a conical shape, in view of Stenkvist, in order to facilitate collecting a tissue sample from a patient’s cervix.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Cobian in view of Auttebery (U.S. Patent Application Publication No. 20060240413).
Regarding claim 7, Cobian discloses the invention substantially as claimed, except for the contact part being formed of a quadrangular member with a protrusion. However, Cobian teaches that body (14) of the tissue collection device may define different shapes (para. [0054]) and may include protrusions (Figs. 8A-11; paras. [0079]-[0093]).
Auttebery, a reference in the gynecologic instrument field of endeavor, teaches forming a contact part of a tissue collection device (500) such
that a contact part is formed of a quadrangular member (annotated Fig. 5D below); and
a protrusion (505) is formed on a contact surface formed on an outer periphery of the quadrangular member for contacting tissue (para. [0044]) to facilitate positioning along the cervix to collect a tissue sample (para. [0045]).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the device of Cobain such that
the contact part is formed of a quadrangular member, and
a protrusion is formed on a contact surface formed on an outer periphery of the quadrangular member and is in contact with the affected part,
in view of Auttebery, in order to facilitate collecting a tissue sample from a patient’s cervix.
Regarding claim 8, Auttebery teaches wherein the contact part includes a plurality of the quadrangular members (each flange (522) forms a quadrangular member; Fig. 5C; para. [0042]).
Claims 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Cobian in view of Lonky (U.S. Patent Application Publication No. 20130267870).
Regarding claim 17, Cobian discloses the invention substantially as claimed, except for the device including a light irradiation part.
Lonky, a reference in the gynecologic instrument field of endeavor, teaches providing a device with a light irradiation part (light source; para. [0078]) that irradiates the affected part with light to allow direct visualization of tissue during a procedure (para. [0078]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the device with a light irradiation part that irradiates the affected part with light, in view of Lonky, in order to allow a user to visualize and directly inspect tissue while collecting a tissue sample from a patient.
Regarding claim 21, Cobian discloses a virus removal system (sample acquisition device (160) is capable of removing a virus, such as by abrasion; Fig. 12; para. [0029]) comprising:
a virus removal device according to claim 1 (explained above):
a control part (handle; annotated Fig. 12 above) that controls the drive source and the operation part (paras. [0094]-[0099]),
wherein the control part operates a position of the operation part, thereby scraping tissue of the affected part with the contact part (para. [0094]-[0099]).
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The device of Cobian discloses the invention substantially as claimed, except for a detection part.
Lonky, a reference in the gynecologic instrument field of endeavor, teaches providing a device with a detection part (camera; para. [0078]) that detects a position of the affected part to allow direct visualization of tissue during a procedure (para. [0078]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the device with a detection part that detects a position of the affected part and configure the control part (i.e., the handle of Cobian) to operate a position of the operation part based on a detection result of the detection part, in view of Lonky, in order to allow a user to visualize and directly inspect tissue to effectively position the device while collecting a tissue sample from a patient.
Response to Arguments
Applicant's arguments filed March 6, 2026 have been fully considered but they are not persuasive.
On pages 8-10 of the Response, Applicant argues that Cobian does not disclose “a contact surface configured to be in contact the affected part in the contact part, wherein the contact surface has projections and recesses, the projections or the recesses are formed in a lattice shape on the contact surface,” as recited in claim 1. These arguments are not persuasive.
Claim 1 recites inter alia projections or recesses formed in a “lattice shape.” Claim 1 does not recite a lattice structure itself, but a structure of projections or recesses that form the shape of a lattice.
The term lattice includes the meaning “a regular geometrical arrangement of points or objects over an area or in space” (https://www.merriam-webster.com/dictionary/lattice; retrieved March 27, 2026).
Thus, the claimed “lattice shape” encompasses a shape of a regular geometrical arrangement of objects over an area of the contact part. Such interpretation is consistent with the Specification because Fig. 3A depicts projections (21a) and recesses (21b) forming shape of a regular geometrical arrangement of objects (i.e., the projections and recesses) over an area of contact part (21).
Cobian discloses a contact part having such a lattice shape. Annotated Fig. 2A of Cobian, reproduced below, depicts a cross-section of body (14) having a contact surface with projections and recess visible in cross-section.
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Annotated Fig. 1 of Cobian, reproduced below, depicts a perspective view of body (14) with the recesses extending longitudinally and latitudinally about the surface of the body and with the projections formed between recesses also extending longitudinally and latitudinally about the surface of the body.
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The projections and recesses of body (14) form a regular geometrical arrangement over the outer area of the body; thus, constituting a “lattice shape” as recited in claim 1. Therefore, Cobian meets the claim limitation “the projections or the recesses are formed in a lattice shape on the contact surface,” recited in claim 1.
On page 8 of the Response, Applicant proffers an overly narrow interpretation of the term “lattice” to require the limitations of “a structure made of strips of material. . . characterized by long narrow pieces of material crossing over each other.” (Response pg. 8). This interpretation does not comport with the broadest reasonable interpretation of the claim at least because the definition is not consistent with the Specification.
Paragraph [0013] of the Specification merely discloses that the projections and recesses “may be formed in a lattice shape on the contact surface.” (Spec. para. [0013]). Figs. 3A-3B of the Drawings Figures, reproduced below, merely depicts projections (21a) and recesses (21b) on a contact part (21).
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Notably absent from paragraph [0013] of the Specification and Figs. 3A-3B is any disclosure or depiction of strips of material or long narrow pieces of material crossing over each other forming the lattice.
Thus, neither the Specification nor the Drawings provides detailed features of the lattice that would indicate to a person having ordinary skill in the art that a lattice requires strips of material or long narrow pieces of material crossing over each other. Therefore, Applicant’s proffered definition of “lattice” is not consistent with the Specification.
On page 9 of the Response, Applicant argues that the lattice shape of Cobian “[is] not made of strips of material and [is] not long narrow pieces of material crossing over each other.” (Response pg. 9). This argument is not persuasive because the features upon which applicant relies are not recited in the rejected claim(s).
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As explained above, the claimed “lattice shape” does not require strips of material or long narrow pieces of material crossing over each other under the broadest reasonable interpretation of the claim.
For all the reasons above, Cobian meets each and every limitation of claim 1, thus anticipating the claimed invention.
Conclusion
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/JONATHAN A HOLLM/Examiner, Art Unit 3771