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 .
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 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for “a transition from the straight first leg to the straight second leg” and “a width (w) between the straight first leg and the second straight leg operable to receive a spinous process” when the straight first and second legs each have a length greater than 0 and less than or equal to 6 cm in length, does not reasonably provide enablement for “a transition from the straight first leg to the straight second leg” and “a width (w) between the straight first leg and the second straight leg operable to receive a spinous process” when the straight first leg and the straight second leg are absent. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The claim recites a straight first leg and a straight second leg and then recites that they may be absent, and further recites a transition from the straight first leg to the straight second leg, and one having ordinary skill in the art would not be able to ascertain even with routine experimentation how to make a blade with a transition from a straight first leg to a straight second leg, when the straight first and second legs do not exist, nor could the straight first and second legs receive a spinous process when they do not exist. The specification is not enabling for an embodiment where there is a transition from a straight first leg to a straight second leg, when the straight first and second legs do not exist. It appears that claim 1 has been amended in a manner to generically cover multiple embodiments, however the specification does not provide support for one embodiment incorporating the features of the various embodiments as recited, nor are there any embodiments where the straight first and second legs are absent but also exist so that the transition extends from them. 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 1-7 & 12 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 at Lines 3-4 recites the limitation “wherein the straight first leg is either absent or has a length less than or equal to 6.0 cm in length”, Lines 7-8 recite the limitation “wherein the straight second leg is either absent or has a length less than or equal to 6.0 cm in length”, Line 9 recites “a transition from the straight first leg to the straight second leg”, and Lines 9-11 recite “wherein a width between the straight first leg and the straight second leg is operable to receive a spinous process”, which renders the claim indefinite as it is unclear how the straight first and second legs can be both absent but also present with the transition and receiving a spinous process. The specification in paragraph [0039] states that “there is no lower limit to the length of the legs 102, 106… The lengths L1, L2 may either or both be zero, thus leaving only the transition”. However, in the scenario when only the transition is left, straight first and second legs would not exist and thus would not be recited in the claim. Thus, since first and second legs are being positively recited, they cannot be claimed as being absent as both scenarios cannot exist together. It is suggested that if the Applicant is intending to recite the embodiment of Fig. 3D in claim 1, the claim should be amended to remove the straight first and second legs limitations as they do not exist in this embodiment. A generic claim would not be appropriate to cover the both the embodiments of Figs. 2A-2D and Figs. 3A-3D due to this structural difference. It is further noted that the limitations of Claim 2, Claim 4, Claim 5, Claim 6, & Claim 7 are further indefinite based on the straight first and second legs being absent. These claims further recite clarifying structural features of the legs which are indefinite if the legs are absent. Appropriate correction is required.
Claim 12 at Lines 1-2 recites the limitation “the straight second leg of the blade”. There is insufficient antecedent basis for this limitation in the claim as there is only a straight first leg recited in Claim 8. For purposes of examination, Lines 1-2 are being interpreted as “wherein the straight first leg defines a band…”. Appropriate correction is required.
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.
Claim(s) 8-10, 13-15 & 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Brien (US PG Pub No. 2017/0296160).
Regarding Claim 8, O’Brien discloses a retractor blade (420, Fig. 14B, Paragraphs [0146-0152]), comprising: a straight first leg (See Fig. 14B depiction and notations below) of the retractor blade having an end joined to an end of a shank (lower end of 420, See Fig. 14B depiction and notations below), wherein the shank is configured to be fixedly joined to a shank spreader (handle portion 440, Figs. 14A, 16A); and a transition (See Fig. 14B depiction and notations below) arcuately extending from a second end of the straight first leg from 90 degrees (there is about an angle of 90 between the first leg and the transition as seen in Fig. 14B) and terminating in a free end (lowermost end surface of transition as seen in Fig. 14B depiction below), wherein a distance between the straight first leg and the free end is capable of receiving a spinous process (The device is fully and structurally capable of being used along the spinal column with the tips of the blades arranged between and receiving two adjacent spinous processes as recited in the functional language above).
PNG
media_image1.png
736
757
media_image1.png
Greyscale
Regarding Claim 9, O’Brien discloses wherein the end of the straight first leg is joined to a face (outside face of 420 of the end of the shank; See Fig. 14B depiction and notations above).
Regarding Claim 10, O’Brien discloses wherein the transition is arcuate (See Fig. 14B depiction and notations above).
Regarding Claim 13, O’Brien discloses wherein the free end is arcuate and defines an apex (See Fig. 14B depiction and notations above).
Regarding Claim 14, O’Brien discloses a spinal retractor (400, Figs. 14A-B, 16A, Paragraphs [0146-0152]), comprising: a first blade (right blade 420, Fig. 14B) comprising; a straight first leg (See examiner annotated Fig. 14B above) having an end (upper end, See examiner annotated Fig. 14B above) joined to an end of a first shank (414); a straight second leg (See examiner annotated Fig. 14B above) having a free end (See examiner annotated Fig. 14B above), the straight second leg oriented parallel to the straight first leg; and a transition (See examiner annotated Fig. 14B above) from a second end of the straight first leg to the straight second leg (See examiner annotated Fig. 14B above), wherein a distance between the straight first leg and the straight second leg is capable of receiving a spinous process (The device is fully and structurally capable of being used along the spinal column with the tips of the blades arranged between and receiving two adjacent spinous processes as recited in the functional language above); a second shank (412, Fig. 14B) opposing the first shank; a shank spreader (440, Fig. 14A) in spreadable communication with the first shank and the second shank; and a ratchet (toothed rack, not labeled, Fig. 14A) in ratcheting communication with the shank spreader (Paragraph [0160]).
Regarding Claim 15, O’Brien discloses a second blade (left blade 410, Fig. 14B) comprising: a straight first leg (See examiner annotated Fig. 14B above) having an end joined to an end of a second shank; a straight second leg (See examiner annotated Fig. 14B above) having a free end (See examiner annotated Fig. 14B above), the straight second leg oriented parallel to the straight first leg; and a transition (See examiner annotated Fig. 14B above) from the straight first leg to the straight second leg, wherein a distance between the straight first leg and the straight second leg is suitable for receiving a spinous process (The device is fully and structurally capable of being used along the spinal column with the tips of the blades arranged between and receiving two adjacent spinous processes as recited in the functional language above).
Regarding Claim 17, O’Brien discloses wherein the shank spreader comprises: a first member (left arm portion of 440) having a first handle (rear end of left handle, Fig. 14A) and the first shank (Fig. 14A), and having a first pivot joint (rounded handle portion of left arm at pivot 430) between the first shank and the first handle; and a second member (right arm portion of 440) having a second handle (rear end of right handle, Fig. 14A) and a second shank (412), and having a second pivot joint (concave handle portion of right arm at pivot 430) between the second handle and the second shank (Fig. 14A).
Regarding Claim 18, O’Brien discloses wherein the first shank and the second shank each include a 90 degree turn (410 & 412 each include a 90 degree turn at their front faces along the distal ends thereof where the front face creates an L-shape when extending outwardly to the second legs).
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.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien (US PG Pub No. 2017/0296160).
Regarding Claim 11, O’Brien discloses the claimed invention as stated in Claim 8, and further discloses wherein the transition is a partially circular segment (See Fig. 14B depiction above), but does not disclose the transition having a radius between 0.15 cm and 1.0 cm +/- 10%. However, in Paragraph [0159], O’Brien does disclose that a pin 500 which can be inserted between the first and second legs of each blade “may have a length of from about 3” to about 4” and Fig. 16A shows the pins 500 engaged with the blades of the retractor. O’Brien further discloses in Paragraph [0157] that “The height of a protrusion 516 (of the pin 500) can vary and be based, in part, upon the height of each detent 414, 424”.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the radius of the transition between the straight legs of each retractor of O’Brien to be from 0.15 cm to 1.0 cm +/- 10% as taught by O’Brien based on the specific needs of a patient and a surgeon’s preference for a particular procedure since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233.
Regarding Claim 12 as best understood, O’Brien discloses the claimed invention as stated in claim 8, and further discloses wherein the straight first leg of the blade defines a band (428) having a height (h) (top to bottom height of 428), but does not disclose the band height (h) being from 0.3 cm to 4.0 cm +/-10%. However, in Paragraph [0159], O’Brien does disclose that a pin 500 which can be inserted between the first and second legs of each blade “may have a length of from about 3” to about 4” and Fig. 16A shows the pins 500 engaged with the blades of the retractor. O’Brien further discloses in Paragraph [0157] that “The height of a protrusion 516 (of the pin 500) can vary and be based, in part, upon the height of each detent 414, 424”.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the overall height of each band of each blade of the retractor of O’Brien to be from 0.3 cm to 4.0 cm +/- 10% as taught by O’Brien based on the specific needs of a patient and a surgeon’s preference for a particular procedure since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claims 16 & 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 21 is allowed. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Arguments
Applicant’s amendments, filed 12/03/25, have overcome the objections to claims 5, 6, 11, 12, & 20.
Applicant’s amendments, filed 12/03/25, have overcome the 112(b) rejections for claims 1, 5, 6, 8, 11, & 12.
In regards to Applicant’s arguments, filed 12/03/25, with respect to the rejection of Claims 8 & 14 and the contention that the claimed straight first leg is joined to a shank on one end and a transition on the other, whereas O’Brien’s comparable structure is free at one end and joined at the other and thus O’Brien contains no such teaching: As seen in the office action above and specifically as depicted in the examiner annotated Fig. 14B above, O’Brien discloses a retractor blade (420, Fig. 14B, Paragraphs [0146-0152]), comprising: a straight first leg of the retractor blade having an end (upper portion of 1st leg, See Fig. 14B depiction and notations below) joined to an end of a shank (lower end of 420, See Fig. 14B depiction and notations below); and a transition (See Fig. 14B depiction and notations below) arcuately extending from a second end of the straight first leg (lower end of 1st leg, See Fig. 14B depiction and notations below) from 90 degrees and terminating in a free end (lowermost end surface of transition as seen in Fig. 14B depiction below). The transition arcuately extends between the straight first and second legs entirely from the first end to the second end of the legs as seen in the examiner annotated Fig. 14B since the transition portion is the structural component which connects the first and second legs along the distal most end of each blade. Thus, the Applicant’s argument has been fully considered but is not persuasive as O’Brien discloses the claimed invention as stated above.
In response to Applicant's argument that “In contrast to the claimed invention, O’Brien places the blades directly under his device which tends to obstruct the view, requiring a surgeon to reposition either himself or the device to visualize different portions of the surgical field at different times,” it is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to Applicant’s arguments, filed 12/03/25, with respect to the rejection of Claim 21: The Applicant’s arguments are persuasive and the rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775