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 .
Claim Objections
Claims 4 and 22 are objected to because of the following informalities:
In claim 4, “colouring” should instead read “coloring”
In claim 22, “analysing” should instead read “analyzing”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the claim recites the limitation “generating the measure for improved application of the base plate using machine learning.” However, Applicant’s disclosure does not properly explain how machine learning will be used; the only mention of machine learning is within claim 24, and Applicant’s specification does not recite the use of machine learning nor provide any further explanation. It is not clear what data set is being provided to train the machine learning model, nor is it explained what kinds of algorithms would be employed in consequent data generation, analysis, or decision-making. Furthermore, as of the effective filing date, artificial intelligence—including specifically machine learning—is a quickly changing and evolving field within the art, and as such, it would not be obvious to one skilled in the art how it is being applied in the claimed invention. See MPEP § 2163.03(V).
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 1-15, 17, 20, and 22-24 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.
Regarding Claim 1, the term “a generally cylindrical body” is a relative term which renders the claim indefinite. The term “generally cylindrical” 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. Applicant’s specification does offer some examples of what a “generally cylindrical body” may include: “an overall shape resembling a cylinder, for example, but not exclusively, including, a pipe- or conduit-like element… also entails implementations wherein the body and/or the peripheral surface thereof does not have to be perfectly rounded or circular or to have a continuous, unabrupt extent… can include shapes resembling an oval or ellipse when viewed in cross section” (p. 9). However, it remains unclear to what degree the “overall shape” must “resembl[e] a cylinder” in order to be considered “generally cylindrical.” Additionally, the quoted section includes some non-exclusive examples, but the scope of the claim remains unascertainable because (1) it is unclear whether what follows the phrase “for example” is part of the claimed invention and (2) the non-exclusivity of those examples would include elements not actually disclosed. Therefore, the claim is indefinite. This limitation is also recited in claims 9-10 and 17.
Claims 2-15, 17, 20, and 22-24 are rejected for depending upon claim 1.
Further regarding Claims 7-8, the term “tacky” is a relative term which renders the claims indefinite. The term “tacky” 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. Page 12 of Applicant’s specification reads “By ‘tacky’ is meant slightly sticky;” however, it remains unclear what degree of stickiness is encompassed by this limitation, e.g., whether certain materials may be “too sticky” or “not sticky enough.”
Further regarding Claim 17, the term “the base plate has a diameter approximating or slightly greater than a diameter of the artificial ostomy” is a relative term which renders the claim indefinite. The terms “approximating” and “slightly greater than” are 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. Applicant’s specification states the following: “whether the diameter of the opening approximates or is slightly greater than a diameter of the artificial ostomy, such as the diameter of the opening being 1-2 mm greater than the diameter of the artificial ostomy” (p. 15). However, since the provided value of “1-2 mm” is simply an example, it remains unclear how close in value the diameter of the base plate would have to be to the value of the diameter of the artificially ostomy in order to be “approximating” or “slightly greater than.”
Claim Rejections - 35 USC § 102
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 4,981,465 (hereinafter “Ballan”).
Regarding Claim 1, Ballan discloses an artificial ostomy comprising a generally cylindrical body (fig. 3: cylindrical body 26) having a peripheral surface (figs. 1, 3: curved siding 28 of cylindrical body) and a first end surface (figs. 1, 3: end 22) and a second end surface (figs. 1, 3: end 24), wherein a liquid-absorbing material is provided on the peripheral surface of the body (col. 5, lines 3-7: “The cover may also be prepared from a hydrocolloid in sheet or film form;” col. 5, lines 28-40: “comes into contact with the moisture… the hydrocolloid will absorb water and thereby form a slimy layer;” col. 8, lines 22-30: “a body 26… is held in that state by a thin cover or wrapping 28”).
Regarding Claim 2, Ballan further discloses the liquid-absorbing material is configured to form a gel on the peripheral surface of the body upon contact with liquid (col. 5, lines 3-7: “The cover may also be prepared from a hydrocolloid in sheet or film form;” col. 5, lines 28-40: “comes into contact with the moisture… the hydrocolloid will absorb water and thereby form a slimy layer;” Examiner notes hydrocolloids are known to form a gel when put in contact with liquid).
Regarding Claim 3, Ballan further discloses the liquid-absorbing material comprises a hydrocolloid (col. 5, lines 3-7: “The cover may also be prepared from a hydrocolloid in sheet or film form;” col. 5, lines 28-40: “comes into contact with the moisture… the hydrocolloid will absorb water and thereby form a slimy layer”).
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.
Claims 1, 4, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0051048 (hereinafter “Wooldridge”) in view of US 2006/0079855 (hereinafter “Hooper”).
Regarding Claim 1, Wooldridge discloses an artificial ostomy comprising a generally cylindrical body having a peripheral surface (figs. 4-5: artificial stoma having a generally cylindrical body, the curved siding being the peripheral surface) and a first end surface (fig. 3B: right/back end of artificial stoma 24 near base 32) and a second end surface (fig. 3B: left/front end of artificial stoma 24).
Wooldridge does not disclose a liquid-absorbing material. However, Hooper discloses a liquid-absorbing material is provided on the peripheral surface of the body (fig. 4; par. 0039: “the actual stoma is illustrated as a portion of the colon 39 is brought through slit 31. As described above, when a portion of a colon 29 (FIG. 1) may be raised through the abdominal wall incision, a stoma is created;” par. 0045: “In demonstrating a colostomy, the wearer may collect the colon-fashioned cloth and attach it to the front side of body portion 12;” Examiner notes the artificial ostomy is made of cloth, which is a liquid-absorbing material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material of Hooper for the peripheral surface of the artificial ostomy of Wooldridge because cloth is well-known to be inexpensive and it can be fashioned to form the appropriate shape, such as part of the colon (Hooper, par. 0045).
Regarding Claim 4, Wooldridge modified by Hooper further discloses the liquid-absorbing material comprises a coloring agent (Hooper, par. 0031: “colon 27 may be fashioned in materials having a general color comparable to the actual organs in the human body;” Examiner notes for the cloth to be of a color comparable to an organ, a coloring agent must have been applied to it). The combination of the artificial ostomy having a peripheral surface of Wooldridge with the cloth material of Hooper described above for claim 1 would have included this coloring agent.
Regarding Claim 7, Wooldridge modified by Hooper further discloses the peripheral surface of the body is tacky (Hooper, par. 0045: “In demonstrating a colostomy, the wearer may collect the colon-fashioned cloth and attach it to the front side of body portion 12;” Examiner notes the peripheral surface is made of cloth and is interpreting such material to be tacky/sticky under the broadest reasonable interpretation of the term due to its tendency of static cling). The combination of the artificial ostomy having a peripheral surface of Wooldridge with the cloth material of Hooper described above for claim 1 would have included this property.
Regarding Claim 8, Wooldridge modified by Hooper further discloses one or both of the first end surface and the second end surface are tacky (Hooper, par. 0045: “In demonstrating a colostomy, the wearer may collect the colon-fashioned cloth and attach it to the front side of body portion 12;” Examiner again notes the peripheral surface is made of cloth and is interpreting such material to be tacky/sticky under the broadest reasonable interpretation of the term due to its tendency of static cling). The combination of the artificial ostomy having a peripheral surface of Wooldridge with the cloth material of Hooper described above for claim 1 would have included this property.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper as applied to claim 1 above, and further in view of CN 109830161 (hereinafter “Liu”).
Regarding Claim 5, modified Wooldridge does not disclose the artificial ostomy is formed of silicone or polyurethane. However, Liu discloses the artificial ostomy is formed of a silicone material or a polyurethane material (p. 3: “said ostomy model 2 is silicon rubber model;” figs. 1-2: Examiner notes artificial ostomy appears to have a distinct internal portion and peripheral surface).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the silicone rubber material of Liu with the artificial ostomy of Wooldridge because the silicone rubber material can enhance the overall quality of the simulation (Liu, p. 6) since silicone rubber is well-known within the industry to be a high-quality material used in such medical devices.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper and Liu as applied to claim 5 above, and further in view of JP 2003/210503 (hereinafter “Watanabe”).
Regarding Claim 6, Wooldridge modified by Liu discloses a silicone rubber but not an addition-curing two-part silicone rubber. However, Watanabe discloses a medical model device in which the silicone material comprises an addition-curing two-part silicone rubber (par. 0004: “The human body approximated skin product according to claim 1 or 2, which is dried. In the present invention, the room temperature vulcanizing type silicone rubber includes… two-component RTV silicone rubbers”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific addition-cured two-part silicone rubber of Watanabe as the silicone rubber material of modified Wooldridge because this particular curing process improves the strength of the device (such as tear strength) (Watanabe, par. 0004).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper as applied to claim 1 above, and further in view of a 2020 CPR Savers & First Aid Supply item listing “Oval Ostomy” (hereinafter “CPR Savers”).
Regarding Claim 9, Wooldridge discloses the cylindrical body has a height approximating the height of a real ostomy (par. 0025) but does not explicitly disclose exact dimensions. However, CPR Savers discloses the generally cylindrical body has a height from the first end surface to the second end surface of 10-100 mm (p. 8: size of artificial ostomy/stoma is 1” x 1 2/8”, or 25.4 mm x 31.75 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific height of the artificial ostomy of CPR Savers as the height of the ostomy of modified Wooldridge since Wooldridge already discloses its artificial ostomy is meant to model a real ostomy without disclosing any specific dimension (Wooldridge, par. 0025), and CPR Savers merely provides such a dimension that also models that of a real ostomy (CPR Savers, p. 8)
Regarding Claim 10, Wooldridge discloses the cylindrical body has a diameter approximating the diameter of a real ostomy (par. 0025) but does not explicitly disclose exact dimensions. However, CPR Savers discloses an outer diameter of the generally cylindrical body is in a range of 10-70 mm (p. 8: size of artificial ostomy/stoma is 1” x 1 2/8”, or 25.4 mm x 31.75 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific diameter of the artificial ostomy of CPR Savers as the diameter of the ostomy of modified Wooldridge since Wooldridge already discloses its artificial ostomy is meant to model a real ostomy without disclosing a specific dimension (Wooldridge, par. 0025), and CPR Savers merely provides such a dimension that also models that of a real ostomy (CPR Savers, p. 8)
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper as applied to claim 1 above, and further in view of US 4,439,162 (hereinafter “Blaine”).
Regarding Claim 11, modified Wooldridge does not explicitly disclose an internal passage with two openings. However, Blaine discloses the body comprises an internal passage extending between a first opening in the first end surface and a second opening in the second end surface of the body (col. 6, lns. 5-15: “stomas 73 and 74 are formed with openings which are connected to the intestinal reservoir 10”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the internal passage described by Blaine with the artificial ostomy of Wooldridge in order to increase the realism and to provide more specific training/teaching (Blaine, col. 8, lns. 44-52).
Regarding Claim 12, Wooldridge modified by Blaine further discloses the internal passage is configured to allow flow of a fluid between the first opening in the first end surface and the second opening in the second end surface (col. 8, lns. 44-52: “For teaching ostomy care, the intestinal reservoir 10 is filled either via one of ostomies 73 or 74 or via the rectal passage and drainage or excretion at the ileostomy or colostomy is effected”). The combination of the artificial stoma of Wooldridge with the internal passage of Blaine described above for claim 11 would have included this allowance for a flow of fluid.
Regarding Claim 13, Wooldridge modified by Blaine further discloses a system for advancing the fluid through the internal passage (col. 8, lns. 44-52: “drainage or excretion at the ileostomy or colostomy is effected;” Examiner notes this system of drainage or excretion inherently involves advancing the fluid), the system adapted to make the fluid enter the internal passage at the first opening and adapted to make the fluid exit the internal passage at the second opening (col. 8, lns. 44-52: “the intestinal reservoir 10 is filled… via the rectal passage and drainage or excretion at the ileostomy or colostomy is effected;” Examiner further notes the fluid enters the internal passage on one end at exits at the other). The combination of the artificial stoma of Wooldridge with the internal passage of Blaine described above for claim 11 would have included this system for advancing the fluid.
Regarding Claim 14, Wooldridge modified by Blaine further discloses a base connected to the first end surface of the body (figs. 1, 9-12: base is the body/skin of mannequin, which is connected to the first end of each of ostomies 73-74). The combination of the artificial stoma of Wooldridge with the internal passage of Blaine described above for claim 11 would have included this base.
Regarding Claim 15, Wooldridge modified by Blaine further discloses the system for advancing fluid is integrated with the base (figs. 9-12; “drainage or excretion at the ileostomy or colostomy is effected;” Examiner notes the system of drainage or excretion, which inherently involves advancing the fluid, is integrated within the base). The combination of the artificial stoma of Wooldridge with the internal passage of Blaine described above for claim 11 would have included this base-integrated system.
Allowable Subject Matter
Claims 17, 20, and 22-24 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and (specifically in regards to claim 24) 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 17, as presented, the combination of all the elements of claim 17 do not appear in a single reference of prior art. Additionally, based on the art of record, it does not appear that it would have been obvious to a person having ordinary skill in the art at the time the application was filed to combine various pieces of the cited prior art to obtain each and every limitation as currently required by the independent claims. Specifically, the previously cited prior art Wooldridge fails to disclose, teach, or suggest “applying liquid to the liquid-absorbing material to form a gel on the peripheral surface of the generally cylindrical body” and “inspecting a distribution pattern of the gel on a proximal surface of the base plate.” Additional relevant art fails to cure this deficiency: for example, Hooper teaches a method for training surgeons on performing an ostomy, and Blaine teaches a method for providing basic maintenance exercises (such as dressing the ostomy) and demonstrating the movement of the internal fluid/waste. In other words, although the demonstration tool described in claim 17 has been rendered obvious over prior art, the prior art of record does not appear to cover the claimed method of using that apparatus.
Claims 20 and 22-24 would be allowable because they depend upon and further narrow the scope of claim 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE DOSHER whose telephone number is (571) 272-4842. The examiner can normally be reached Monday - Friday, 10 a.m. - 6 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, Dmitry Suhol can be reached at (571) 272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.G.D./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715