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 Rejections - 35 USC § 112
Claims 1-2 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 first non-visual area portion" in lines 21-22. There is insufficient antecedent basis for this limitation in the claim. For the purpose of this examination, this limitation is interpreted to mean --the first non-thorn area portion--.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
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 non-obviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2008/0027486) in view of Gross et al. (US 11,007,296) and Lee (KR 20190107641).
Regarding claim 1, Jones et al. disclose a medical thread assembly (100; Figure 1) for cannula insertion, the medical thread assembly comprising: a medical thread including: a thorn area portion (126/130/128) having a length greater than twice a length of a cannula (a cannula is not structurally required by the claims, a cannula could be designed with a length as claimed), arranged in a central area thereof in a lengthwise direction, and formed on a surface thereof with thorns (104); a first non-thorn area portion (127) extending from one end in the lengthwise direction of the thorn area portion and excluding a thorn formed on a surface thereof; and a second non-thorn area portion (129) extending from an opposite end in the lengthwise direction of the thorn area portion and excluding a thorn formed on a surface thereof; and an insertion needle (110 or 112), having a length longer than a length of the cannula and an outer diameter smaller than an inner diameter of the cannula (a cannula is not structurally required by the claims, a cannula could be designed with a length and diameter as claimed), and having a rear end accommodated in an open end of the first non-thorn area portion and then pressed and fit at both side in a width direction to fix and couple the open end of the first non-thorn area portion (Figure 2C; the above limitation is being treated as a product by process limitation, that is As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference; the swaged suture-needle connection of Jones et al. is considered structurally equivalent to the product by process structure above; a tapering of needle width is not required by the claim), wherein the insertion needle is inserted through a rear opening of the cannula and then drawn out through a front opening of the cannula, and is cut and removed at the first non-thorn area portion after at least a part of the first non-thorn area portion is drawn out from the front opening (the thread assembly of Jones et al. is capable of being used as claimed with an appropriately sized cannula).
Jones et al. fail to disclose that the needle is configured as a cylinder and has a front end closed in a blunt shape.
Gross et al. teach that it is known in the art to make needles for similar thread assemblies with a cylindrical shape and having a blunt end (col. 9, lines 17-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Gross et al. to have provided the needle of Jones et al. with a cylindrical shape and blunt end as claimed in order to take advantage of these known features suitable for similar needles.
Jones et al. fail to disclose that the thorns are configured to have only an inverted trapezoidal shape having lateral sides slantingly opening to both sides in the lengthwise direction while protruding outward perpendicular to the lengthwise direction.
Lee discloses a thread assembly having thorns (11B, 11C) shaped as claimed (Figures 2B and 2C) and which allows improved tissue fixation with easier manufacturing (¶[0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided thread assembly of Jones et al. with the thorn shape of Lee in order to allow improved tissue fixation and easier manufacturing.
Regarding claim 2, Jones et al. disclose that the thorn area portion has a length of 16 to 50 cm (¶[0038]) but fails to disclose the first and second non-thorn area lengths as claimed.
However, Jones discloses adjusting the length of these areas depending on the procedure being performed and the length of needle being used (¶[0038]-[0041]). As such, these lengths are disclosed as result-effective variables which are adjusted depending on the procedure and needle length. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the non-thorn areas with a length as claimed as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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