Detailed Action
This is the first office action on the merits for US application number 18/925,763.
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 with traverse of Species c) of Figs. 17-18 in the reply filed on April 20, 2026 is acknowledged. The traversal is on the ground(s) that the species share the same core inventive concept with only minor variations that do not result in distinct inventions, the claims do not recite mutually exclusive limitations, the number of species is reasonable and would require consideration of the same art, therefore there is no burden.
The argument that the inventions are not distinct is not found persuasive because the species election is required due to the mutually differences in the species, i.e. not the commonalities as argued. For example, Figs. 1 and 2 show a grip with an open groove in the top with no seams, a generally T-shaped tongue-and-groove engagement of the slidable member and the first slide, a blade with a right end that appears to also have a tongue-and-groove style engagement with the grip, no screws or holes on the exterior of the grip head, two screws on the exterior of the grip base, and a single sleeve on the aiming piece; however, Figs. 17 and 18 show the grip having a closed top with a seam, a generally rectangular engagement of the slidable member and the first slide, a blade with a right end that appears to generally rectilinear portion that slides into engagement with the grip that involves something that resembles a pin, two-three screws or holes on the exterior of the grip head, on screws on the exterior of the grip base, and two sleeves on the aiming piece. That is, 6 sets of mutually exclusive features between those 2 species alone. Further, the argument that the claims do not recite mutually exclusive limitations is irrelevant to the required species election, as such is not based on the claimed invention, and is also erroneous as claims 13/14 provide a worm screw of Figs. 17 and 18 and claim 15 provides a rack with an unlock button that specification p. 12 lines 14-15 and p. 13 lines 8-9 discloses for Figs. 19-21. Accordingly, Examiner has unmistakably shown distinctness between the species.
The argument that there is the number of species is reasonable and would require consideration of the same art therefore there is no burden is not found persuasive because, although there would be some overlap, considering and searching such a multitude of mutually exclusive features requires each feature to be considered and searched. That is, while there are only four species claimed, there are many mutually exclusive features in each species, which provides a substantial burden to consider as well as search.
The requirement is still deemed proper and is therefore made FINAL.
As to claim 3, the limitation of the grip is constituted by two half-shells does not read on the elected species as such has not been disclosed or shown for Figs. 17 and 18. Further, specification p. 13 line 12 discloses the grip is constituted by two half-shells for the non-elected species of Figs. 19-21. Therefore, claim 3 does not read on the elected species.
As to claim 4, the limitation of the grip is constituted by a flat surface and two bent parallel branches does not read on the elected species as such has not been has not been disclosed or shown for Figs. 17 and 18. Further, specification p. 7 line 26 discloses the grip is constituted by a flat surface and two bent parallel branches for the non-elected species of Figs. 1-13 and specification p. 9 line 29 discloses the grip is constituted by a flat surface and two bent parallel branches for the non-elected species of Figs. 14-16. Therefore, claim 4 does not read on the elected species.
Claim 6 depends from claim 4 and subsequently does not read on the elected species.
As to claim 10, the limitation of “the trigger comprises a measuring graduation” has been interpreted as intended to read “the slidable member comprises a measuring graduation” which does not read on the elected species as such has not been disclosed or shown for Figs. 17 and 18. Further, specification p. 10 line 11 discloses the trigger comprises a measuring graduation for the non-elected species of Figs. 14-16. Therefore, claim 10 does not read on the elected species.
As to claim 15, the limitation of a rack with an unlock button does not read on the elected species as such has not been disclosed or shown for Figs. 17 and 18. Further, specification p. 12 lines 14-15 and p. 13 lines 8-9 discloses a rack with an unlock button for the non-elected species of Figs. 19-21. Therefore, claim 15 does not read on the elected species.
Accordingly, claims 3, 4, 6, 10, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement filed June 10, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. That is, a complete copy of NPL #3 has not been received as only 3 pages, which are numbered as pages 2-4 have been received.
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(s) 1, 2, 5, 7-9, and 11-14 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “A reusable surgical guide for osteosynthesis surgery, forming an aimer for guiding and inserting axial wires into bone portions, comprising” in lines 1-2 and the missing nouns prior to “forming” and “comprising”. Examiner is interpreting this as referring to, and suggests amending as, “A reusable surgical guide for osteosynthesis surgery, the reusable surgical guide forming an aimer for guiding and inserting axial wires into bone portions, the reusable surgical guide comprising:”.
Claim(s) 1 recites/recite the limitation "the upper end of the base" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]an upper end of the base.
Claim(s) 1 recites/recite the limitation "the distal end of the head" in line 9. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a distal end of the head”.
Claim(s) 2 is/are unclear with regards to “whose concavity” in line 2 and to whom “whose” is intended to refer, i.e. the base or the circular-arc shape, as well as “a distal end of the head of said grip” in lines 2-3 that is in addition to “a distal end of the head of said grip” of claim 1 line 10. Examiner is interpreting this as referring to, and suggests amending as, “the base has a circular-arc shape with a concavity [[is ]]directed towards [[a]]the distal end of the head of said grip.”.
Claim(s) 7 recites/recite the limitation "the at least one cylindrical sleeve comprises an axis of revolution that extends in the sagittal plane of the reusable surgical guide, in the direction of a distal end of the blade," in lines 1-3. There is insufficient antecedent basis for the limitations “the sagittal plane” and "the direction of a distal end of the blade" in the claim. Further, such is unclear as to the meaning of “an axis of revolution” there appears to be nothing disclosed to revolve/rotate and to what “in the direction” is intended to refer or the missing word prior to “in” or if the preceding comma is erroneous. Examiner is interpreting this as referring to, and suggests amending as, “the at least one cylindrical sleeve comprises an axis a sagittal plane[[,]] and in [[the]]a direction of a distal end of the blade,”.
Claim(s) 7 is/are unclear with regards to “said at least one cylindrical sleeve forming a sheath” in lines 3-4 and the intended difference between a sleeve and a sheath as such does not appear to be further limiting. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 9 is/are unclear with regards to “the at least one cylindrical sleeve comprises two parallel cylindrical sleeves whose axes of revolution extend in the sagittal plane of the guide, in the direction of a distal end of the blade,” in lines 1-4 with regards to “whose axes of revolution” in lines 2-3 and to whom “whose” is intended to refer as well as the meaning of “an axis of revolution” there appears to be nothing disclosed to revolve/rotate. Further, there is insufficient antecedent basis for the limitations “the sagittal plane” and "the direction of a distal end of the blade" in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the at least one cylindrical sleeve comprises two parallel cylindrical sleeves comprising axes that extend in the sagittal plane of the guide[[,]] and in [[the]]a direction of a distal end of the blade,”.
Claim(s) 9 is/are unclear with regards to “said two parallel cylindrical sleeves respectively forming a sheath” in line 4 and the intended difference between a sleeve and a sheath as such does not appear to be further limiting. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 11 recites/recite the limitation "the epiphysis of the metatarsus" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “adapted to bear on [[the]]an epiphysis of [[the]]a metatarsus.”.
Claim(s) 13 recites/recite the limitation "the trigger" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “a worm screw for pulling the slidable member.”.
Claim(s) 14 recites/recite the limitation "the trigger" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the worm screw cooperates with the slidable member and.”.
Claim(s) 5, 8, and 12 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fallin et al. (US 2017/0014223, hereinafter “Fallin”).
The claimed phrases “forming” and “formed” are being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. 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. MPEP 2113.
As to claim 1, Fallin discloses a reusable surgical guide (100) capable of use for osteosynthesis surgery (Figs. 8-28, ¶27 discloses use in bone), the reusable surgical guide forming an aimer for guiding and inserting axial wires into bone portions (Figs. 7, 8, 14, 15, and 18-28, ¶27), the reusable surgical guide comprising: a grip (see illustration of Fig. 1, Fig. 1) comprising a base (see illustration of Fig. 1, Fig. 1) and a head (see illustration of Fig. 1, Fig. 1) extending at an upper end of the base (as defined, Fig. 1, i.e. where upper is shown to the right in Fig. 1), the head including a first slide (opening/passage holding 110, Fig. 17) and the base including a second slide (opening/passage holding 132 in Figs. 1 and 16-25); a slidable member (110, Figs. 1, 9, 11, and 17, ¶s 28 and 37; where ¶28 discloses that 110 is engageable with the grip and ¶37 discloses that 304 is similar to 110 and Fig. 11 shows that such is a distinct component from the grip; thus, 110 is capable of sliding within in the grip at least during assembly to achieve the positioning shown in Figs. 1, 9, 11, and 17) capable of sliding in the first slide formed in the head of the grip (Figs. 1, 9, 11, and 17, ¶s 28 and 37; where ¶28 discloses that 110 is engageable with the grip and ¶37 discloses that 304 is similar to 110 and Fig. 11 shows that such is a distinct component from the grip; thus, 110 is capable of sliding within in the grip at least during assembly to achieve the positioning shown in Figs. 1, 9, 11, and 17), wherein the slidable member comprises a through hole (146, 148, Figs. 7 and 8, ¶32) capable of use for the insertion of a wire (186, Figs. 7 and 8, ¶36), wherein an axis of the through hole of the slidable member (vertical along 146 and 148 as shown in Figs. 1, 7, and 8, Figs. 1, 7, and 8) is transverse to a sliding direction of the slidable member in the head of the grip (horizontal along 110 as shown in Figs. 1, 7, and 8, Figs. 1, 7, and 8); a blade (see illustration of Fig. 1, Fig. 1) secured to a distal end of the head of the grip (as defined, Fig. 1, i.e. where distal is shown as the bottom in Fig. 1); and an aiming piece (132, 120) capable of sliding in the second slide formed in the base of the grip (to adjust the angle 195, Fig. 17), said aiming piece comprising at a distal end thereof (162, Fig. 1) at least one cylindrical sleeve (162, Figs. 1 and 21, ¶33 discloses that 162 is cylindrical) capable of supporting at least one wire (Figs. 7 and 8, ¶36).
As to claim 2, Fallin discloses that the base has a circular-arc shape (Fig. 1, ¶31 discloses that 130 is an arc member) with a concavity (Fig. 1) directed towards the distal end of the head of said grip (Fig. 1).
As to claim 5, Fallin discloses that the aiming piece has a circular-arc shape (Fig. 1, ¶31 discloses that 132 is an arc member).
As to claim 7, Fallin discloses that the at least one cylindrical sleeve comprises an axis that extends in a sagittal plane of the reusable surgical guide (Figs. 1 and 21) and in a direction of a distal end of the blade (Figs. 1 and 21), said at least one cylindrical sleeve forming a sheath (Figs. 1, 7, 8, and 21) capable of receiving a barrel (184 of 136, Figs. 2, 5, and 22, ¶s 30 and 36) capable of aiming the at least one wire (Figs. 2, 5, 22, and 24, ¶s 30 and 36).
As to claim 8, Fallin discloses that the sheath includes a longitudinal slot (166, Fig. 7, ¶33), said slot extending in the sagittal plane of said reusable surgical guide (Figs. 1, 7, and 8).
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Claim(s) 1 and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lombardo et al. (US 2005/0033301, hereinafter “Lombardo”).
The claimed phrases “forming” and “formed” are being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. 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. MPEP 2113.
As to claim 1, Lombardo discloses a reusable surgical guide (2100) capable of use for osteosynthesis surgery (Fig. 44, ¶120 discloses use on bone), the reusable surgical guide forming an aimer (Fig. 44) capable of guiding and inserting axial wires into bone portions (Figs. 46-48), the reusable surgical guide comprising: a grip (see ‘Grip Base’ and ‘Grip Head’ in illustration of Fig. 31, Fig. 31) comprising a base (see illustration of Fig. 31, Fig. 31) and a head (see illustration of Fig. 31, Fig. 31) extending at an upper end of the base (as defined, Fig. 31, i.e. where upper is shown at the bottom in Fig. 31), the head including a first slide (2104) and the base including a second slide (212) ; a slidable member (2152, 2106) capable of sliding in the first slide formed in the head of the grip (¶122), wherein the slidable member comprises a through hole (2156, Fig. 45, ¶122) capable of use for the insertion of a wire (Fig. 45 shows drill bit 2250 portion 2258 extending therethrough, Figs. 45-48, ¶102 discloses that 900 is a suture passing pin), wherein an axis of the through hole of the slidable member (along the longest dimension of drill bit 2250 as shown in Fig. 45, Fig. 45) is transverse to a sliding direction of the slidable member in the head of the grip (vertical along 2152 as shown in Fig. 31, Figs. 31 and 45); a blade (see illustration of Fig. 31, Fig. 31) secured to a distal end of the head of the grip (as defined, Fig. 31, i.e. where distal is shown at the left in Fig. 31); and an aiming piece (2200, 2300) capable of sliding (to achieve the position shown in Fig. 31, Fig. 31, ¶121 discloses bore 2112 receiving sleeve 2200, ¶123 discloses being removable for cleaning or use of different sides) in the second slide formed in the base of the grip (Fig. 21 ¶121 discloses bore 2112 receiving sleeve 2200, ¶123 discloses being removable for cleaning or use of different sides), said aiming piece comprising at a distal end thereof (2300, 2206) at least one cylindrical sleeve (Figs. 31 and 44-48) capable of supporting at least one wire (2618, Fig. 48, ¶129).
As to claim 11, Lombardo discloses that the blade has an L shape (as defined, see illustration of Fig. 31, Fig. 31) comprising a proximal portion (as defined, Fig. 31, i.e. where proximal is shown at the right in Fig. 31) extending parallel to the head of the grip (as defined, Fig. 31), a longitudinal aperture (2102, Fig. 31), and a distal portion (as defined, Fig. 31, i.e. where distal is shown at the left in Fig. 31) capable of bearing on an epiphysis of a metatarsus (if one chooses to position the device as such, as ¶120 discloses use on bone).
As to claim 12, Lombardo discloses that the blade has a rectilinear shape (as defined, see illustration of Fig. 31, Fig. 31) comprising a proximal portion (as defined, Fig. 31, i.e. where proximal is shown at the right in Fig. 31) extending parallel to the head of the grip (as defined, Fig. 31) and a longitudinal aperture (2102, Fig. 31).
As to claim 13, Lombardo discloses a worm screw (2166) capable of pulling the slidable member (when engaged with 2106, Figs. 31 and 44, ¶122).
As to claim 14, Lombardo discloses a first end of the worm screw (upper end of 2166 as shown in Fig. 31) cooperates with the slidable member (as defined, Fig. 31) and an opposite end of the worm screw (2106, bottom end of 2166 as shown in Fig. 31) comprises a knob (2106, Fig. 1, ¶122).
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Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whittaker et al. (US 2002/0133165, hereinafter “Whittaker”).
The claimed phrases “forming” and “formed” are being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. 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. MPEP 2113.
As to claim 1, Whittaker discloses a reusable surgical guide (5) capable of use for osteosynthesis surgery (Figs. 15-34, ¶26 discloses use on bone), the reusable surgical guide forming an aimer (Figs. 21-25) capable of guiding and inserting axial wires into bone portions (Figs. 21-25), the reusable surgical guide comprising: a grip (see ‘Grip Base’ and ‘Grip Head’ in illustration of Fig. 1, Fig. 1) comprising a base (see illustration of Fig. 1, Fig. 1) and a head (see illustration of Fig. 1, Fig. 1) extending at an upper end of the base (as defined, Fig. 1, i.e. where upper is shown at the bottom in Fig. 1), the head including a first slide (45) and the base including a second slide (see illustration of Fig. 1, Figs. 1-4, 6, and 8-10); a slidable member (25, i.e. see illustration of Fig. 1, Fig. 1) capable of sliding in the first slide formed in the head of the grip (Figs. 19-21, ¶31 discloses retaining 25 in slide 15 with screw 50, ¶42 discloses insertion of the slidable member into bone, ¶44 discloses positioning 10 on 25), wherein the slidable member comprises a through hole (35, Fig. 1, ¶31) capable of use for the insertion of a wire (Fig. 21 shows trocars 100 extending therethrough as well as guidewire 140, Fig. 21, ¶44 discloses use to direct orientation of crosspins 255, 260), wherein an axis of the through hole of the slidable member (generally along the longest dimension of left 100 as shown in Fig. 8, Fig. 8) is transverse to a sliding direction of the slidable member in the head of the grip (vertical the slidable member as shown in Fig. 8, Fig. 8); a blade (see illustration of Fig. 1, Fig. 1) secured to a distal end of the head of the grip (as defined, Fig. 1, i.e. where distal is shown at the left in Fig. 1); and an aiming piece (58, 80, 85, i.e. see illustration of Fig. 1, Fig. 1) capable of sliding (to achieve the position shown in Fig. 1, i.e. along the second slide, Figs. 1-4, 6, and 8-10, ¶34 discloses the removable connection) in the second slide formed in the base of the grip (Figs. 1-4, 6, and 8-10), said aiming piece comprising at a distal end thereof (left end of 80 and 85 as shown in Fig. 1, Fig. 1) at least one cylindrical sleeve (Figs. 1 and 11) capable of supporting at least one wire (100s, Figs. 1 and 21-33, ¶45).
As to claim 9, Whittaker discloses that the at least one cylindrical sleeve comprises two parallel cylindrical sleeves (as defined, Fig. 1) comprising axes (along each of 80 and 85, Fig. 1) that extend in the sagittal plane of the guide (Fig. 1) and in a direction of a distal end of the blade (as defined, Fig. 1, i.e. to the left as shown in Fig. 1), said two parallel cylindrical sleeves respectively forming a sheath (Fig. 1) capable of receiving a barrel (Figs. 1, 11, and 21-33) capable of aiming the at least one wire (Figs. 1, 11, and 21-33).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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 or telephone the Examiner.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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