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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Regarding claim 1, “a female for” should be “a female component for”. Additionally, “the bone” should be “a bone”. Additionally, “an external D-Shaped” should be “an external D-shape”.
Regarding claim 6, “components proportionally” should be “components are proportionally”. Additionally, “the proximal bone” should be “a proximal bone”. Additionally, “the growth plate in the distal epiphysis” should be “a growth plate in a distal epiphysis” or similar language.
Appropriate correction is required.
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 1-18 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, from which all other claims depend, a transition phrase is missing between the preamble and body of the claim. See MPEP 2111.03. For the purpose of examination, it is assumed the assembly comprises two the two components.
Additionally regarding claim 1, from which all other claims depend, it is unclear what is meant by the male and female components being lockable (whether it is achieved via their respective D-shapes or by external locking fasteners, like screws, attaching to the components). For the purpose of examination, it is assumed that the components are lockable via their respective shapes (see paragraph [0033] of the present application, which describes locking of the male and female components via their respective D-shapes).
Additionally regarding claim 1, from which all other claims depend, it is unclear what structural or functional features is required by the phrase “wherein the threads are synched”. For the purpose of examination, it is assumed the threads may be simultaneously located in bone.
Regarding claim 2, it is unclear what is meant by “located externally partially proximally, or distally”. For the purpose of examination, it is assumed the external D-shape can be at least partially located on a proximal or distal end of the female component.
Regarding claim 3, it is unclear what is meant by the burnishing being “special”.
Regarding claim 4, “the head” lacks antecedent basis. For the purpose of examination, it is assumed the female component has a head.
Regarding claim 5, “the head” lacks antecedent basis. For the purpose of examination, it is assumed the male component has a head.
Regarding each of claims 7 and 8, it is unclear what is meant by thread leads being “simple”. Additionally, it is unclear whether the thread can have only one lead or whether it must have multiple leads. For the purpose of examination, it is assumed there must be multiple leads.
Regarding each of claims 9 and 10, “the female head” lacks antecedent basis. For the purpose of examination, it is assumed the female component has a head.
Regarding claim 11, “partially on a midshaft portion only” is indefinite, as it is unclear whether the shaft is partially D-shaped such that it is D-shaped on only a midshaft portion, or whether the shaft is only partially D-shaped on a midshaft. For the purpose of examination, the former interpretation is assumed.
Regarding claim 13, “the smooth distal shaft” lacks antecedent basis.
Regarding claim 14, “the head” lacks antecedent basis.
Regarding claim 15, “the head” lacks antecedent basis.
Regarding claims 16-18, these claims are directed to methods, but are missing transition phrases (see MPEP 2111.03) and it is unclear whether they describe method steps to be performed or are describing functional capabilities of the nail assembly of claim 1. For the purpose of examination, the latter is assumed.
Regarding claim 16, “the child’s bone” lacks antecedent basis.
Regarding claim 17, it is unclear what the nail assembly is inserted “simultaneously” with. For the purpose of examination, it is assumed the male and female components are at least partially inserted simultaneously as one connected piece. Additionally, “the intramedullary canal of the bone” lacks antecedent basis.
Regarding claim 18, it is unclear what the nail assembly is extracted “simultaneously” with. For the purpose of examination, it is assumed the male and female components are at least partially extracted simultaneously as one connected piece. Additionally, “the intramedullary canal of the bone” lacks antecedent basis.
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 1-3, 6, 12, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0064475 (Polat) in view of U.S. Patent No. 7,753,915 (Eksler) and U.S. Patent No. 6,524,313 (Fassier).
Regarding claim 1, Polat discloses a telescopic nail assembly (1) of two components (3/5) a male component (3) nested in a female (5) for the purpose of gliding inside the bone without rotating (see paragraph [0026] and claim 8) wherein the male component has a shaft that is D-Shaped (see paragraph [0026] and Fig. 2), the male component is lockable (see paragraphs [0029] and [0031]) and the female component is proximally threaded (6) and lockable (see paragraphs [0029] and [0031]).
Polat is silent on whether the female component has an external D-shape. However, Eksler discloses that parts of a telescopic device can have non-circular external shapes to inhibit rotation of the parts to provide rigidity and stable alignment within the fractured bone (see Fig. 3 and col. 5, lines 23-42), and Polat discloses a D-shape as a non-circular shape that can inhibit rotation (see paragraph [0026]). Regarding claim 2, Eksler discloses wherein the D-Shape of the female component can be located externally partially proximally, or distally (see Fig. 3 and col. 5, lines 29-42; female non-circular shape is located externally at least partially distally). Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the female component have an external D-shape in order to provide rigidity and stable alignment within a fractured bone (see Eksler, col. 5, lines 23-42).
Polat fails to disclose the male component is distally threaded, but instead shows a distal corkscrew (7). However, Fassier discloses a telescopic nail (10) having male (18) and female (14) components, wherein both components are threaded (28 and 40) at respective, opposite ends. Regarding claim 12, Fassier discloses wherein the distal thread on the male component is smaller than the shaft diameter (see col. 3, line 67 – col. 4, line 3; thread 28 is tapered to be smaller than diameter of at least portion 30 of shaft). Regarding claim 13, Fassier discloses wherein a smooth distal shaft (30) on the male component is greater than the distal thread (see col. 3, line 67 – col. 4, line 3). Regarding claim 15, Fassier discloses wherein the head (28) of the male component has a self-tapping feature that eases the insertion of the male component in the bone (see col. 3, line 63 – col. 4, line 3). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the male component distally threaded as suggested by Fassier instead of corkscrewed as such a modification merely involves substituting one type of mechanism for anchoring an intramedullary nail in bone (screw threads) for another type of mechanism (corkscrew) for anchoring an intramedullary nail in bone without any unpredictable results.
Regarding claim 3, the prior art suggests a female component having an external D-shape (see analysis of claim 1 above). Regarding how the shape is obtained, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 6, Polat discloses wherein the length of the threads on both components proportionally matched in such a way that when the female component head is completely buried in the proximal bone the male component passes through the growth plate in the distal epiphysis (see paragraph [0029]).
Claims 1-3, 6, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0091285 (Venturini) in view of Polat and Eksler.
Regarding claim 1, Venturini discloses a telescopic nail assembly (1) of two components (2/10) a male component (10) nested in a female (2) for the purpose of gliding inside the bone, the male component is distally threaded (30) and the female component is proximally threaded (20), wherein the threads are synched (see Fig. 28).
Venturini is silent on the male component having a shaft that is D-shaped, and thus, lockable to the female component. However, Polat discloses a telescopic nail assembly (1) of two components (3/5) a male component (3) nested in a female (5) for the purpose of gliding inside the bone without rotating (see paragraph [0026] and claim 8) wherein the male component has a shaft that is D-Shaped (see paragraph [0026]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the male component to be D-shaped in order to allow for relative sliding of the male and female components while also hindering relative rotation (see Polat, paragraphs [0026] and [0027]).
Venturini is silent on the female component having an external D-shape, and thus, lockable relative to bone. However, Eksler discloses that parts of a telescopic device can have non-circular external shapes to inhibit rotation of the parts to provide rigidity and stable alignment within the fractured bone (see Fig. 3 and col. 5, lines 23-42), and Polat discloses a D-shape as a non-circular shape that can inhibit rotation (see paragraph [0026]). Regarding claim 2, Eksler discloses wherein the D-Shape of the female component can be located externally partially proximally, or distally (see Fig. 3 and col. 5, lines 29-42; female non-circular shape is located externally at least partially distally). Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the female component have an external D-shape in order to provide rigidity and stable alignment within a fractured bone (see Eksler, col. 5, lines 23-42).
Regarding claim 3, the prior art suggests a female component having an external D-shape (see analysis of claim 1 above). Regarding how the shape is obtained, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 6, Venturini discloses wherein the length of the threads on both components proportionally matched in such a way that when the female component head is completely buried in the proximal bone the male component passes through the growth plate in the distal epiphysis (see Fig. 28).
Regarding claim 16, Venturini discloses a method wherein the telescopic nail assembly of claim 1, wherein the total length of the assembly is adjusted to the child's bone without intra-operative cutting (see paragraphs [0146]-[0155] and Figs. 23-28; no intra-operative cutting of the assembly necessary during adjustment of total length of assembly).
Regarding claim 17, Venturini discloses a method wherein the telescopic nail assembly of claim 1 is inserted simultaneously in the intramedullary canal of the bone (see paragraphs [0146]-[0155] and Figs. 23-28; nail assembly is inserted simultaneously as one connected assembly in the intramedullary canal of a bone).
Regarding claim 18, Venturini discloses a method wherein the telescopic nail assembly of claim 1 is extracted simultaneously from the intramedullary canal of the bone in case of a hardware removal surgery or for revision surgery (see paragraph [0135]; see also paragraphs [0046]-[0155] and Figs. 23-28, insertions of the nail in one piece may be reversed so that the nail may also be extracted in one piece).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Polat in view of Eksler and Fassier, and further in view of U.S. Patent Application Publication No. 2020/0214743 (Eckhof) and U.S. Patent Application Publication No. 2007/0233122 (Denis).
Regarding claims 4 and 5, Polat discloses wherein the heads of the male and female components have additional distal and proximal fixation features (see paragraphs [0029] and [0031]), but is silent regarding wherein the heads of the male and female components have multiple lead threads. However, Eckhof discloses threaded bone anchors (160) that can have multiple lead threads (see paragraph [0099]), and it would be obvious to modify the heads of the female and male components to have multiple lead threads in order to provide enhanced bone purchase (see Eckhof, paragraph [0099]).
Polat is silent on the head of the female being tapered. However, Denis discloses a bone anchor (50) in which the tip (56) is tapered (see paragraph [0019]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the female head tapered to facilitate entry into bone (see Denis, paragraph [0019]).
Claims 4, 5, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Venturini in view of Polat and Eksler, and further in view of Eckhof.
Regarding claims 4 and 5, Venturini discloses the female head being tapered (see paragraph [0122]). Venturini is silent on the heads of the male and female components having additional distal and proximal fixation features. However, Polat suggests wherein the heads of the male and female components have additional distal and proximal fixation features (see paragraphs [0029] and [0031]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention for the heads to include additional fixation features to facilitate anchoring the heads in bone (see Polat, paragraphs [0029] and [0031]).
Venturini is silent regarding wherein the heads of the male and female components have multiple lead threads. However, Eckhof discloses threaded bone anchors (160) that can have multiple lead threads (see paragraph [0099]), and it would be obvious to modify the heads of the female and male components to have multiple lead threads in order to provide enhanced bone purchase (see Eckhof, paragraph [0099]).
Regarding claims 7 and 8, Venturini is silent on wherein the female component thread leads can be simple, double, triple quadruple, or any combination of pitch and lead to adapt to the bone anatomy; and wherein the male component thread leads can be simple, double, triple quadruple, or any combination of pitch and lead to adapt to the bone anatomy. However, Eckhof discloses threaded bone anchors (160) that can have double, triple, or quadruple bone threads (see paragraph [0099]), and it would be obvious to modify the female and male components to have such threads in order to provide enhanced bone purchase (see Eckhof, paragraph [0099]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Polat in view of Eksler and Fassier, and further in view of Eckhof.
Regarding claims 7 and 8, Polat and Fassier are silent on wherein the female component thread leads can be simple, double, triple quadruple, or any combination of pitch and lead to adapt to the bone anatomy; and wherein the male component thread leads can be simple, double, triple quadruple, or any combination of pitch and lead to adapt to the bone anatomy. However, Eckhof discloses threaded bone anchors (160) that can have double, triple, or quadruple bone threads (see paragraph [0099]), and it would be obvious to modify the female and male components to have such threads in order to provide enhanced bone purchase (see Eckhof, paragraph [0099]).
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Polat in view of Eksler and Fassier, and further in view of U.S. Patent Application Publication No. 2022/0304730 (Beckett).
Regarding claims 9 and 14, Polat is silent on wherein the female head has a proximal hole that offers the possibility of proximal locking; and wherein the head of the male component has a distal locking hole. However, Beckett discloses a telescopic intramedullary nail (100) in which a female component (102) and a male component (106 each have locking holes (104/105/108), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide locking holes in the male and female components in order to provide additional fixation of the intramedullary nail to bone via locking screws (see Beckett, paragraph [0031]).
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Venturini in view of Polat and Eksler, and further in view of Beckett.
Regarding claims 9 and 14, Venturini is silent on wherein the female head has a proximal hole that offers the possibility of proximal locking; and wherein the head of the male component has a distal locking hole. However, Beckett discloses a telescopic intramedullary nail (100) in which a female component (102) and a male component (106 each have locking holes (104/105/108), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide locking holes in the male and female components in order to provide additional fixation of the intramedullary nail to bone via locking screws (see Beckett, paragraph [0031]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Polat in view of Eksler and Fassier, and further in view of Denis.
Regarding claim 10, Polat is silent regarding wherein the female head has two self- tapping features that help to ease the insertion process of the female component in bone. However, Denis discloses a bone screw (50) that has two self-tapping features that ease insertion of the screw into bone (see paragraph [0019]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the female head have two self-tapping features in order to facilitate entry and purchase of the female component into bone (see Denis, paragraph [0019]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Venturini in view of Polat in view of Eksler, and further in view of Denis.
Regarding claim 10, Venturini is silent regarding wherein the female head has two self- tapping features that help to ease the insertion process of the female component in bone. However, Denis discloses a bone screw (50) that has two self-tapping features that ease insertion of the screw into bone (see paragraph [0019]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the female head have two self-tapping features in order to facilitate entry and purchase of the female component into bone (see Denis, paragraph [0019]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Polat in view of Eksler and Fassier, and further in view of U.S. Patent Application Publication No. 2011/0251643 (Miladi).
Regarding claim 11, Polat is silent on wherein the shaft of the male is D-Shaped partially on a midshaft portion only. However, Miladi discloses a spinal bone rod (2) that need only be partially non-circular on a midshaft portion only in order to prevent it from undesired rotation (see paragraph [0055]). Thus, it would be obvious to have the male component be D-shaped partially on a midshaft portion only, as such a feature still allows for relative sliding of the rod while preventing against undesired rotation (see Miladi, paragraph [0055]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Venturini in view of Polat and Eksler, and further in view of Miladi.
Regarding claim 11, Venturini is silent on wherein the shaft of the male is D-Shaped partially on a midshaft portion only. However, Miladi discloses a spinal bone rod (2) that need only be partially non-circular on a midshaft portion only in order to prevent it from undesired rotation (see paragraph [0055]). Thus, it would be obvious to have the male component be D-shaped partially on a midshaft portion only, as such a feature still allows for relative sliding of the rod while preventing against undesired rotation (see Miladi, paragraph [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773