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 1 and 5 is/are objected to due to the following informalities:
In claim 1, line 2, “releases a substance to be administered that is accommodated” should be corrected to “accommodates a substance that is to be administered
In claim 1, line 5, the term “and” should be replaced with a comma followed by the phrase “wherein the cylindrical main body portion is”.
In claim 5, line 3 should be corrected to recite “the proximal end
In claim 5, line 4-5 should be corrected to recite “a liquid permeation portion configured to permeate a liquid and a pressing portion configured to press the ejection portion”.
In claim 5, line 7 should be corrected to recite “the distal end
In claim 5, lines 8-9 should be corrected to recite “accommodates a release portion configured to discharge the substance to be administered to an outside by sliding the ejection portion”.
In claim 5, lines 11-13 should be corrected to recite “wherein the site of the sliding region is composed of a material harder than a material of the deformable member and capable of retaining the shape of the inner cavity against an external force”
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 5 is/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.
Claim 5, line 9-10 recites state “are composed of the deformable member”. The phrase uses “are” and therefore appears to refer to both the proximal end and distal end. However, since lines 9-10 are part of the passage that refers to the distal end, it is unclear if the “deformable member” is intended to refer to both ends (Fig. 1 shows both ends having deformable member 10a) or if it is intended to refer to the distal end only. For the sake of examination, the “deformable member” in lines 9-10 is being interpreted to refer to the distal end only. Therefore, Applicant is suggested to amend claim 5, lines 9-10 to recite “wherein the site is [[are]] composed of the deformable member” to overcome rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites “the deformable member is composed of a member having a structure deformable along the shape of the in-vivo lumen” but claim 1 already recites “a deformable member that is deformable along a shape of the in-vivo lumen” (in order to be deformable in the manner set forth in claim 1, the deformable member already has to be “composed of a member having a structure deformable” in the manner claimed), so claim 3 fail to further limit the subject matter of the claims upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 is rejected under 35 U.S.C. 101 because in the phrases “An administration device that is indwelled in an in-vivo lumen” and ““a deformable member that is deformable long a shape of the in-vivo lumen” in claim 1, the “in-vivo lumen” is positively recited as a part of the invention. To overcome this rejection, the “in-vivo lumen” needs to be functionally recited. Applicant is suggested to amend claim 1 to recite ““An administration device that is configured to be indwelled in an in-vivo lumen” and “a deformable member that is configured to be deformable along a shape of the in-vivo lumen” to overcome rejection of claim 1.
Claims 2-5 is/are rejected by virtue of their dependency on claim 1.
In claim 3, recites “a structure deformable along the shape of the in-vivo lumen” and the “in-vivo lumen” is also positively recited and therefore suffers the same issue as claim 1. Applicant is suggested to amend claim 3 to recite “a structure configured to be deformable along the shape of the in-vivo lumen” to overcome rejection of claim 3.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 20160279399 A1, herein Lee).
Regarding claim 1, Lee discloses an administration device (device 702 in Fig. 7) that is indwelled in an in-vivo lumen (suitable for insertion of the device through a lumen in the patient's urethra [0067]) and releases a substance to be administered (osmotic agent 710 to cause the liquid drug formulation 732 to be displaced [0066]) that is accommodated (an elongated flexible tube 706 having a lumen therein loaded with a liquid drug formulation 732 [0066]; see also liquid drug formulation 732 within tube 706 in Fig. 7), the administration device comprising:
a cylindrical main body portion (housing 704 in Fig. 7; see also cylindrical shape of tube 706 of housing 704 in Fig. 7) having an inner cavity (see central lumen 805 in Fig. 8; it is set forth in Para [0023] and [0049] that Fig. 8 can be interpreted to be a cross section view of Fig. 7) in which the substance to be administered can be accommodated (an elongated flexible tube 706 having a lumen therein loaded with a liquid drug formulation 732 [0066]) and configured to be able to retain a shape of the inner cavity against an external force (device 702 further includes a retention frame lumen 770 with a retention frame 772 [0067]; when in the retention shape after deployment in the bladder, for example, the device advantageously may resist excretion in response to the forces of urination or other forces[0079]) ; and
an ejection portion that is slidable in a liquid- tight manner in the inner cavity (a fluid piston 720 in the lumen interposed between the osmotic agent 710 and the liquid drug formulation 732; water is imbibed through wall 750, enters the lumen and solubilizes the osmotic agent 710 to form an osmotic solution. Water continues to be imbibed, creating an osmotic pressure, which is relieved by displacement of the fluid piston 720 [0066]),
wherein at least a part of the main body portion is composed of a deformable member (the device 702 is elastically deformable [0079]) that is deformable along a shape of the in-vivo lumen (the device may be elastically deformable between a first shape suitable for insertion through the patient's urethra [0079]).
Regarding claim 2, Lee disclosed all limitations of claim 1. Lee further discloses wherein the deformable member is made of a flexible material (the material from which the housing is formed makes the device capable of being elastically deformed [0082]).
Regarding claim 3, Lee disclosed all limitations of claim 1. Lee further discloses wherein the deformable member is composed of a member having a structure deformable along the shape of the in- vivo lumen (the device may be elastically deformable between a first shape suitable for insertion through the patient's urethra [0079]; it can also be interpreted from [0066] that tube 706 may also deform along lumen due to having flexible feature)
Regarding claim 4, Lee disclosed all limitations of claim 1. Lee further discloses wherein at least one of a proximal end (see proximal end in annotated Fig. 7 below) and a distal end (see distal end in annotated Fig. 7 below) of the main body portion is composed of the deformable member (it can be interpreted that the proximal end and distal end in Fig. 7 is comprised of deformable member since the proximal end and distal end is part of flexible tube 706).
PNG
media_image1.png
436
492
media_image1.png
Greyscale
Annotated Fig. 7 of Lee
Regarding claim 5, Lee disclosed all limitations of claim 4. Lee further discloses wherein:
in the main body portion,
the proximal end which is a site on an upstream side (proximal end can be seen upstream of the sliding region in annotated Fig. 7 above) of a sliding region of the ejection portion (see sliding region in annotated Fig. 7 above, which can be interpreted as the region comprising the osmotic agent 710 and piston 720) in the inner cavity and accommodates a liquid permeation portion (water permeable wall 750 in Fig. 7) permeating a liquid (water is imbibed through wall 750 [0066]) and a pressing portion (osmotic agent 710 in Fig. 7) pressing the ejection portion by an action of the liquid that has permeated the liquid permeation portion (water is imbibed through wall 750, enters the lumen and solubilizes the osmotic agent 710 to form an osmotic solution. Water continues to be imbibed, creating an osmotic pressure, which is relieved by displacement of the fluid piston 720 [0066]), and
the distal end which is a site on a downstream side of the sliding region (distal end can be seen upstream of the sliding region in annotated Fig. 7 above) and accommodates a release portion (dispensing aperture 708 in Fig. 7) discharging to the outside the substance to be administered pressed by sliding of the ejection portion (fluid piston 720 in the lumen interposed between the osmotic agent 710 and the liquid drug formulation 732, wherein the fluid piston 720 is operable to advance in the lumen toward the first end under osmotic pressure generated by the osmotic agent 710 to cause the liquid drug formulation 732 to be displaced (in the direction of the arrow) out of the lumen via the dispensing aperture 708 [0066]), are composed of the deformable member (it can be interpreted that dispensing aperture 708 is made of similar material as tube 706 since aperture 708 is a part of tube 706, and therefore deformable); and
the site corresponding to the sliding region is composed of a material harder than the deformable member capable of retaining the shape of the inner cavity against an external force (the retention frame includes or consists of an elastic wire (may include nitinol alloy wire) [0084]; it can be interpreted that a nitinol alloy may be a harder material than the flexible tube 706; when in the retention shape after deployment in the bladder, for example, the device advantageously may resist excretion in response to the forces of urination or other forces[0079]; retention frame 772 can be seen located near the sliding region in annotated Fig. 7 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20010031277 A1 (Peery): related to an osmotic delivery device.
US 20090202608 A1 (Alessi): related to an osmotic delivery device.
US 5308348 A (Balaban): related to an osmotic delivery device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. 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, Kevin Sirmons can be reached at (571) 272-4965. 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.
/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights