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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 03/24/2026 is acknowledged.
The claims to the non-elected inventions were cancelled by applicant. Election was made without traverse in the reply filed on 03/24/2026.
The amendment submitted 03/24/2026 introduced claims directed to different species as identified below.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
The claims are directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Species A: forceps having first and second arms;
Species B: scalpel having a handle;
Species C: dental instrument
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: 1-3, 7, 8, 10-12, 14-17, 20, and 62.
Species A, B and C lack unity of invention because even though the inventions of these groups require the technical feature of: a surgical instrument, comprising: a handle comprising a contoured compressible grasping surface having a distal handle section, a trough handle section having a diameter, and a proximal handle section arranged along a longitudinal axis of the handle, wherein the distal handle section and the proximal handle section have a larger diameter than the trough handle section, at least the trough section including a plurality of spaced protrusions along a curved outer surface of the handle that compress upon application of manual pressure to the handle, and a surgical instrument mounted on a distal end of the handle wherein the surgical instrument applies a force to tissue or bone during a surgical procedure, a level of the force applied to the tissue or bone corresponding to a level of compression of the manually compressed spaced protrusions, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Dunn. Dunn discloses (fig. 1-8B) a surgical instrument, comprising: a handle 100 comprising a contoured compressible grasping surface having a distal handle section 14, a trough handle section 20 having a diameter, and a proximal handle section 18 arranged along a longitudinal axis of the handle (see fig. 1), wherein the distal handle section and the proximal handle section have a larger diameter than the trough handle section (see fig. 1), at least the trough section 20 including a plurality of spaced protrusions 104 along a curved outer surface of the handle that compress upon application of manual pressure to the handle (see [0046]), and a surgical instrument 40 mounted on a distal end of the handle (see fig. 4A-4B and 8A-8B) wherein the surgical instrument applies a force to tissue or bone during a surgical procedure (see [0045]), a level of the force applied to the tissue or bone corresponding to a level of compression of the manually compressed spaced protrusions (see [0046]-[0047]).
During a telephone conversation with George Blazeski on 04/24/2026 a provisional election was made without traverse to prosecute the invention of species A, claims 1-3, 7, 8, 10-12, 14-17, 20, 51-56 and 62. Affirmation of this election must be made by applicant in replying to this Office action. Claims 57-61 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Claim 52 is 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 52 recites the limitation "the first arm" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 52 recites the limitation "the second arm" in line 2-3. 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.
Claims 1-3, 7, 8, 16, 17, 51, 52, 56, and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dunn (US 20150305762 A1).
Regarding claim 1 Dunn discloses (fig. 1-8B) a surgical instrument, comprising:
a handle 100 comprising a contoured compressible grasping surface having a distal handle section 14, a trough handle section 20 having a diameter, and a proximal handle section 18 arranged along a longitudinal axis of the handle (see fig. 1), wherein the distal handle section and the proximal handle section have a larger diameter than the trough handle section (see fig. 1), at least the trough section 20 including a plurality of spaced protrusions 104 along a curved outer surface of the handle that compress upon application of manual pressure to the handle (see [0046]), and
a surgical instrument 40 mounted on a distal end of the handle (see fig. 4A-4B and 8A-8B) wherein the surgical instrument applies a force to tissue or bone during a surgical procedure (see [0045]), a level of the force applied to the tissue or bone corresponding to a level of compression of the manually compressed spaced protrusions (see [0046]-[0047]).
Regarding claim 2 Dunn further discloses (fig. 1-8B) the diameter of the proximal handle section 18 is greater than the diameter of the distal handle section 14 (see fig. 4B, 8B and [0041]).
Regarding claim 3 Dunn further discloses (fig. 1-8B) the diameter of the proximal handle section 18 is in a range from 12.5-28 mm (1.6-2cm = 16 to 20cm; see [0041]), or wherein the diameter of the proximal handle section is in a range from 14-24 mm (1.6-2cm = 16 to 20cm; see [0041]), and wherein the diameter of the distal protruding handle section 20 is in a range from 10-18 mm (1.2-1.8cm = 12 to 18cm; see [0041]) or wherein the diameter of the distal handle section is in a range from 12- 18 mm (1.2-1.8cm = 12 to 18cm; see [0041]).
Regarding claim 7 Dunn further discloses (fig. 1-8B) the diameter of the trough handle section is less than the diameter of the distal handle section (see fig. 1, 5, and [0041]).
Regarding claim 8 Dunn further discloses (fig. 1-8B) the diameter of the trough handle section is in a range from 8-18 mm (1-1.5cm = 10 to 15cm; see [0041]), or the diameter of the trough handle section is in a range from 9-15 mm (1-1.5cm = 10 to 15cm; see [0041]).
Regarding claim 16 Dunn further discloses (fig. 1-8B) the compressible grasping surface has a substantially circular (see fig. 7 and [0048]).
Regarding claim 17 Dunn further discloses (fig. 1-8B) the handle is composed of a rigid polymer, or wherein the handle and the contoured compressible grasping surface are composed of a polymer material that is liquid impermeable and sterilizable (see claim 11).
Regarding claim 51 Dunn further discloses (fig. 1-8B) the surgical instrument comprises a forceps 47 (see [0047]), the handle comprising a first arm (44 plus engaged arm of 40) connected to a second arm (46 plus engaged arm of 40) that compress to reduce a distance between a distal end of the first arm and a distal end of the second arm (see fig. 4A-4B, 8A-8B, and [0047]) .
Regarding claim 52 Dunn further discloses (fig. 1-8B) the diameter of the trough handle section comprises a first trough section of the first arm and a second trough section on the second arm (see fig. 4B and 8B), the first trough section and the second trough section being compressed together to define the diameter of the trough handle section (see fig. 4B and 8B).
Regarding claim 56 Dunn further discloses (fig. 1-8B) the surgical instrument comprises a molded plastic material (see [0008]).
Regarding claim 62 Dunn further discloses (fig. 1-8B) the handle comprises a 3D printed handle material (see [0008]).
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.
Claims 10-12, 14, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn.
Regarding claim 10, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 1. Dunn is silent regarding the contoured compressible grasping surface comprises an elastic body that compresses in a range of 1% to 20% of a thickness of the elastic body.
However, 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 device of Dunn to have the contoured compressible grasping surface comprises an elastic body that compresses in a range of 1% to 20% of a thickness of the elastic body since it has been held that “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 Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Dunn would not operate differently with the claimed compression range since the body would still compress to close the forceps. Further, applicant places no criticality on the range claimed, indicating simply that the range is “preferably” within the claimed range (published specification [0043]).
Regarding claim 11, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 1. Dunn is silent regarding a spacing between the spaced protrusions is at least 0.5 mm.
However, 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 device of Dunn to have a spacing between the spaced protrusions is at least 0.5 mm since it has been held that “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 Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Dunn would not operate differently with the claimed spacing since the protrusions would still provide increased texture for gripping. Further, applicant places no criticality on the range claimed, indicating simply that the spacing “can” be within the claimed range (published specification [0048]).
Regarding claim 12, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 11. Dunn further discloses (fig. 1-8B) the spaced protrusions comprise raised nobs, hexagonal protrusions or diamond-shaped protrusions (see [0048]), and wherein a height of the spaced protrusions enables the hand of the user to avoid contacting fluids on the textured or roughened surface of the contoured compressible grasping surface. The language “a height of the spaced protrusions enables the hand of the user to avoid contacting fluids on the textured or roughened surface of the contoured compressible grasping surface” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Dunn meets the structural limitations of the claim, and a height of the spaced protrusions is capable of enabling the hand of the user to avoid contacting fluids on the textured or roughened surface of the contoured compressible grasping surface. Dunn teaches that the protrusions can have a larger height (see [0055]). Furthermore a user’s hand touching the protrusions would raise it above the surface of the handle and allow fluid to flow in the empty space instead if touching a user.
Regarding claim 14, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 11. Dunn further discloses (fig. 1-8B) each spaced protrusion is dome-shaped (see fig. 5, 19 and [0048]).
Regarding claim 15, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 11. Dunn further discloses (fig. 1-8B) each spaced protrusion has a rounded portion and a flat plateau top (see [0048] and fig. 23).
Regarding claim 20, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 1. Dunn further discloses (fig. 1-8B) the protrusions have a height and compress by a distance upon application of manual force (see [0055]).
Dunn is silent regarding the compression distance is in a range between 6-12% of the height.
However, 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 device of Dunn to have the compression distance is in a range between 6-12% of the height since it has been held that “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 Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Dunn would not operate differently with the claimed compression distance since the body would still compress to close the forceps. Further, applicant places no criticality on the range claimed, indicating simply that the range is the claimed range in “preferred” embodiments (published specification [0044]).
Claims 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn in view of Aufaure et al. (US 20100298865 A1).
Regarding claim 53 Dunn further discloses (fig. 1-8B) the first arm and the second arm comprise respective arms (arms of 40) and a first molded portion 44 attached to the first respective arm and a second molded portion 46 attached to the second respective arm (see [0008] and [0045]).
Dunn is silent regarding the respective arms are metal arms.
However Aufaure, in the same filed of endeavor, teaches an injection molded handle over forceps, wherein the arms of the forceps are metal (see [0030]).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify Dunn to have the respective arms be metal arms as taught by Aufaure, for the purpose of having forceps whose working points coincide accurately during use (see Aufaure [0009]).
Regarding claim 54, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 53. Dunn further discloses (fig. 1-8B) the first molded portion includes an inset (snap) that receives the first metal arm (see [0045]).
Regarding claim 55, Dunn discloses the claimed invention substantially as claimed, as set forth above for claim 53. Dunn further discloses (fig. 1-8B) the first molded portion clips (snap) to the first metal arm (see [0045]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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