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 .
Response to Amendments
The amendments and remarks filed on 29DEC2025 have been entered and considered.
Claims 1, 3-8, 10, 11, & 13-20 are currently pending.
Claim 1 has been amended.
Claim 12 has been canceled.
Claims 13-20 have been added.
Claim 10 was previously withdrawn.
Claims 1, 3-8, 11, & 13-20 are under examination.
New matter has been found in Claims 1, 14-15, & 18.
Applicant's amendments filed 29DEC2025 regarding the rejections under 35 U.S.C 103 have been fully considered and are found to obviate the rejections. Therefore, the rejections have been withdrawn.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites “a distal of the coating” in Line 2. This appears to missing a word and should instead recite “a distal end of the coating”.
In claim 14, the limitation of “wherein, in the main body, each of the plurality of pores comprises a pore size of 30 µm to 60 µm and a porosity is 60% to 80%” should be changed to -- wherein, in the main body, each of the plurality of pores comprises a pore size of 30 µm to 60 µm and the main body has a porosity of 60% to 80%-- to be consistent with [0061] of the USPGPub. version of the specification, which discloses the main body, micro needle, having a porosity of 60 to 80%.
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.
Claims 1, 3-8, 11, & 13-20 are 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(s) 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.
Regarding Claim 1:
The claim recites “comformally with a uniform thickness” in line 16. When the reference does not disclose that the drawings are to scale and is silent as to dimensions, arguments based on measurement of the drawing features are of little value. See Hockerson-Halberstadt, Inc. v. Avia Group Int’l, 222 F.3d 951, 956, 55 USPQ2d 1487, 1491 (Fed. Cir. 2000) (The disclosure gave no indication that the drawings were drawn to scale. "[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.").
Claims 3-8, 11, & 13-20 are further rejected for depending upon rejected independent claim 1.
Regarding Claim 14:
The claim recites “apex angle” in line 2. When the reference does not disclose that the drawings are to scale and is silent as to dimensions, arguments based on measurement of the drawing features are of little value. See Hockerson-Halberstadt, Inc. v. Avia Group Int’l, 222 F.3d 951, 956, 55 USPQ2d 1487, 1491 (Fed. Cir. 2000) (The disclosure gave no indication that the drawings were drawn to scale. "[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.").
Regarding Claim 15:
The claim recites “thickness of the coating is smaller than a size of the pores.” in lines 1-2. When the reference does not disclose that the drawings are to scale and is silent as to dimensions, arguments based on measurement of the drawing features are of little value. See Hockerson-Halberstadt, Inc. v. Avia Group Int’l, 222 F.3d 951, 956, 55 USPQ2d 1487, 1491 (Fed. Cir. 2000) (The disclosure gave no indication that the drawings were drawn to scale. "[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.").
Regarding Claim 18:
The claim recites “same height in the base plate” in line 2. When the reference does not disclose that the drawings are to scale and is silent as to dimensions, arguments based on measurement of the drawing features are of little value. See Hockerson-Halberstadt, Inc. v. Avia Group Int’l, 222 F.3d 951, 956, 55 USPQ2d 1487, 1491 (Fed. Cir. 2000) (The disclosure gave no indication that the drawings were drawn to scale. "[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.").
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, 3-8, 11, & 13-20 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 “uniform thickness.” in claim 1 is a relative term which renders the claim indefinite. The term “uniform thickness.” 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. The term “uniform thickness” depend on the scale of observation, the geometry being referenced, and acceptable measurement tolerances and therefore do not provide a sufficient description of the coating when no reference is additionally described.
Claims 3-8, 11, & 13-20 are further rejected for depending upon rejected independent claim 1.
Regarding Claim 15:
The term “thickness of the coating is smaller than a size of the pores” in claim 15 is a relative term which renders the claim indefinite. The term “thickness of the coating is smaller than a size of the pores” 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. The term “thickness of the coating is smaller than a size of the pores” depend on the scale of observation, the geometry being referenced, and acceptable measurement tolerances and therefore do not provide a sufficient description of the coating when no reference is additionally described.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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