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 .
This is the first office action in response to the above identified patent application filed on 01/19/2024. Claims 1-16 are currently pending and being examined.
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 1-14, 16 and 17 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 ends are located…" in line 8. It is unclear if this recitation is referring back to “the ends of the main body” or “the ends of the tips” as previously recited in lines 4 and 6 respectively. Appropriate correction/clarification is required.
Claims 2-14, 16 and 17 depend from Claim 1 and are rejected accordingly.
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 and 15 are rejected under 35 U.S.C. 102a1 as being anticipated by Patterson et al. (US 10,653,354).
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In regards to Independent Claim 1, and with particular reference to marked-up Figure 10 shown immediately above, Patterson discloses an apparatus (10) for injection into the skin by superficial incision (incision made by the tips 42; as shown in figures 16 and 17) comprising:
a main body (12; refer to figure 8);
two branches (as shown in the marked-up drawings above) disposed at two longitudinal ends (17/36, 19/34) of the main body; and
tips (42) for incision of the skin, the tips protruding from the main body, the tips comprising ends (the ends making the incision);
the apparatus being able to have a configuration in which the ends (of the main body) are located on an entirely curved surface (32), the surface being convex in a longitudinal direction (as shown in figure 10), and
a center of curvature of the surface 32 in a longitudinal plane parallel to the longitudinal direction and the main body 12 are located on a side of the surface (opposite side to the side where the tips 42 are placed on surface 32), and
the two branches are directly linked (interpreted as integrally formed as shown) to each other so as to form a handle (18; refer to marked-up figure 10 above), the main body 12 and the handle 18 being on the side (opposite side to the side where the tips 42 are protruding) of the surface 32.
In regards to Independent Claim 15, and with particular reference to marked-up Figure 10 shown immediately above, Patterson discloses a superficial skin incision method, the method comprising:
a step of rolling an apparatus (10; refer to figures 16 and 17) carrying skin incision tips 42 over the skin of a patient 100,
the step of rolling comprising placing ends of the tips successively in contact with the skin (as illustrated in figures 16 and 17),
the ends being located on an entirely curved surface (32; refer to figure 8),
the surface 32 being convex in a longitudinal direction (refer to figures 10 and 11),
a center of curvature of the surface 32 in a longitudinal plane parallel to the longitudinal direction and a main body 12 are located on a side of the surface (opposite side to the side where the tips 42 are placed on surface 32).
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 2, 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Patterson.
Regarding dependent Claim 2, Patterson teaches the invention as claimed and as disclosed above and further teaches wherein the main body comprises a face (the face of element 32 from which the tips are protruding; refer to figures 10 and 11), the tips (42) protruding from the face, the face being bent, when the apparatus is in the configuration, an average radius of curvature of the face in the longitudinal plane being of a size (figures 16 and 17 shows the device having a size so it fits in the hand of an average size-person).
Patterson does not teach the size is between 7 and 20 centimeters.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have made the device of Patterson so its size is within 7 and 20 centimeters in order for it to fit in the hand of an average size-person and because it has been held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(A).
Further, the Examiner additionally notes that "[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929); MPEP 2144.05(II)(A).
Regarding dependent Claim 3, Patterson teaches the invention as claimed and as disclosed above and further teaches wherein the handle (18) has a shape (partially/half cylindrical ) defined by an axial direction perpendicular to the longitudinal direction, refer to figures 8-11.
Patterson does not teach the shape if fully cylindrical.
It has been held that the configuration of the shape of an apparatus is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the handle of Patterson to have a fully cylindrical shape, since it has been held that the configuration of the shape of an apparatus is a matter of choice absent persuasive evidence that the particular configuration of the claimed apparatus is significant*.See MPEP 2144.04 IV(B).
*The instant application in figure 4 seems to imply the device will perform equally well with other shapes.
Further, the Examiner additionally notes that "[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929); MPEP 2144.05(II)(A).
Regarding dependent Claim 5, Patterson teaches the invention as claimed and as disclosed above and further teaches wherein the face (the face of element 32 from which the tips are protruding; refer to figures 10 and 11) is cylindrical, the cylindrical face being defined by an axial direction (into the paper direction) perpendicular to the longitudinal direction (right to left direction; refer to figures 10 and 11).
Allowable Subject Matter
Claims 4, 6-14, 16 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741
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