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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 28 July 2020. It is noted, however, that applicant has not filed a certified copy of the CN 202010739356.2 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the drawings that show the particle groove having an inner diameter less than the diameter of the radioactive particles or particle strips must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 5 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for grooves being equal to the diameter of the radioactive particles or particle strips, does not reasonably provide enablement for grooves that have diameters less than the radioactive particles or particle strips. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The specification does not disclose embodiments where the particle groove is less than the diameter of the particle or particle strips. There is no guidance as to how this performed and no examples given. It is also not clear how singular atomic particles can have diameters larger than particle grooves.
Based on the description is appears to be that it is supposed to be directed towards the groove body and the not the particle groove.
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 1-12 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 1 recites the limitation "the forward and backward directions " in line 4 and “the outer surface” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-12 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 4 recites the limitation "the radioactive particle grooves" in line 3. There is insufficient antecedent basis for this limitation in the claim. Note that claim 1 only recites “a radioactive particle groove”.
Claims 5 and 6 recite the limitation “the inner diameter and “the radioactive particle grooves” in line 4. There is insufficient antecedent basis for these limitations in the claims. Note that claim 1 only recites “a radioactive particle groove”.
Claim 7 is unclear. It is not clear what is being claimed because it appears to be missing something due to the claim appearing to be a comparison of some type.
Claim 7 recites the limitation "the number" and “the axial direction” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the radioactive particle grooves" in line 3. There is insufficient antecedent basis for this limitation in the claim. Note that claim 1 only recites “a radioactive particle groove”.
Claim 8 recites the limitation "the radioactive particle grooves" in line 4. There is insufficient antecedent basis for this limitation in the claim. Note that claim 1 only recites “a radioactive particle groove”.
Claim 10 recites the limitation “the radioactive particle groove at least comprises a first radioactive particle groove and a second radioactive particle groove”. It is not clear how a singular groove can be two different grooves.
Claim 10 recites the limitation “steps S3-S5” in line 8. However there is no step labeled as S5.
Claim 11 recites the limitation "the guide wire" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
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) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 20926465U (Jiao et al., hereinafter Jiao).
In regards to claim 1 Jiao discloses in figures 1 and 2 a stent for carrying radioactive particles and tumor suppressors (see translation of full document; in particular description section). The device includes the following components:
a body (stent body 1) that is formed by winding metal wires and is a wire mesh having a hollow cavity penetrating through same in the forward and backward directions (the stent body is made by weaving a nickel titanium alloy, equivalent to winding metal wires and being a wire mesh having a hollow cavity penetrating through the body in forward and backward directions.); and
a radioactive particle groove that is formed in the outer surface of the body, is a cylindrical wire mesh having a hollow cavity penetrating through same in the forward and backward directions, and is used for accommodating the radioactive particles or particle strips (11 and 12 are grooves or channels disposed on the outer surface of the body and is also made using the same cylindrical wire mesh used in the stent body and have a hollow cavity penetrating in the forward and backward directions), wherein
the radioactive particle groove comprises a plurality of groove bodies arranged in parallel, and spacing between every two adjacent groove bodies is less than the length of the radioactive particles or the particle strips (figures 1 and 2 show the grooves and channels are in parallel and that the distance between the grooves a is less than the length of the grooves. As shown in figure 1, the source of radioactive particles/strips 12 is longer than the spacing between the groove bodies 11); and
the radioactive particle groove and the body are made of the same material by winding metal wires, or are made of biodegradable material by means of one-step injection molding (grooves or channels disposed on the outer surface of the body are made using the same cylindrical wire mesh used in the stent body).
In regards to claim 2, Jiao discloses the limitation of claim 1. The limitations of claim 2 appear to be a product by process limitation. unless a structural limitation is provided by the process limitation, patentability of product-by-process claims are based on the product itself (see MPEP 2113[R-1]). Therefore, since it appears that the process does not limit the claims in terms of structure, Jiao et al. discloses the radioactive particle groove (see figures 1 and 2 and description in translation), which meets the limitations recited in the instant claim.
In regards to claim 3, Jiao discloses the limitations of claim 1. Applicant has not defined what is the size or requirements of a body unit. Thus, one could choose an arbitrary part of the stent body and define those as body units and make the spacing between the groove bodies the same as between the body units, which allows Jiao to meet the limitations of the claim.
In regards to claim 4, Jiao discloses the limitations of claim 2. In addition, it can be seen in figure 2 that the diameter of the radioparticle grooves that hold the particles (12) is nearly the same size which suggests that the diameter falls within the claimed range.
In regards to claims 5 and 6, Jiao discloses the limitations of claim 1, In addition as shown in figure 2, there are grooves that are formed in a protruding mode (12) and grooves formed in a concave mode (11). It can also be seen in the figures that radioactive particle grooves is equal to the diameter of the particles/particle strips. Due to the current 112 issues of the claims Jiao would meet the current limitations.
In regards to claim 7, Jiao discloses the limitations of claim 1. In addition, as shown in figures 1 and 2 there are a number of radioactive particle grooves in the axial direction of the intracavity radiotherapy apparatus. Due to the 112 issues of the claim, Jiao meets the limitations being claimed.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 20926465U (Jiao et al., hereinafter Jiao) as applied to claim 1 above and further in view of CN 2617400 Y (Teng et al., hereinafter Teng).
In regards to claim 8, Jiao discloses the limitations of claim 1 but does not teach the usage of guidewires and attaching them to either the body or the radioactive particle grooves. In a related area, Teng discloses a radiotherapy device (see description translation). Teng discloses the use of wires attached to the device (see figure 1; attachment to wire 3) in order to assist with drug delivery. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to include a guidewire, as taught by Teng that attaches to the body or radioactive particle grooves of Jiao in order to aid in delivery of therapeutic components.
Conclusion
The examiner notes that, though no art has been applied against claims 9-12 at this time, they are not presently allowable. The question of prior art will be revisited upon resolution of the numerous issues noted above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791