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 3/2/2026 is acknowledged. Accordingly, claims 14-19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 7 is objected to because of the following informalities: The phrase “the nucleus pulposus” lacks proper antecedent basis since this is the first time that this feature is being introduced; accordingly, it is suggested to amend claim 7 to recite [[the]] a nucleus pulposus of the intervertebral disc”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: The term “are” should be inserted before the term “hollow” on line 2 and the term “comprises” on line 2 should be replaced with the term “comprise” in order to be grammatically correct. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The phrase “the nucleus pulposus” on line 2 lacks proper antecedent basis since this is the first time that this feature is being introduced; accordingly, it is suggested to amend claim 9 to recite [[the]] a nucleus pulposus of the intervertebral disc”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The term “fluid” should be inserted before the term “composition” on line 1 in order to maintain consistency of claim language with claim 9. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: The term “the” should be inserted before the term “second” on line 1 in order to be grammatically correct. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The term “the” in the phrase “the disc height” on line 2 should be replaced with the term “a” since this is the first time that a disc height of the untreated [intervertebral] disc is being claimed. The term “intervertebral” should be inserted before the term “disc” on line 2 in order to maintain consistency of claim language with claim 1. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The term “the” in the phrase “the disc height” on line 2 should be replaced with the term “a” since this is the first time that a disc height of the untreated [intervertebral] disc is being claimed. The term “intervertebral” should be inserted before the term “disc” on line 2 in order to maintain consistency of claim language with claim 1. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: A semi-colon should be placed at the end of line 2 and the colon of line 4 should be replaced with a semi-colon. 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 3-7, 9 and 10 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 3 recites that “the first needle is inserted and removed twice” on lines 1-2 and that “the second needle is inserted and removed twice” on lines 2-3, claim 6 recites that “the first or second needle is inserted” on line 1, and claim 7 recites that “the first or second needle is inserted” on line 1. For each of claims 3, 6 and 7, it is unclear if the “inserted” action of the first needle is the same as or different from the “inserting a first needle” step of claim 1 or if the “inserted” action of the second needle is the same as or different from the “inserting a second needle” action of claim 1. Additionally for claim 3, it is unclear if the “removed” action of the first needle is the same as or different from the “removing the first needle” step of claim 1 or if the “removed” action of the second needle is the same as or different from the “removing the second needle” of claim 1. For the sake of examination, the “inserted” and “removed” actions are interpreted as being the same as the “inserting” steps of claim 1. Accordingly, it is suggested to amend claim 3 to recite “wherein the inserting of the first needle into the untreated intervertebral disc of the subject at least one time comprises inserting the first needle twice, the removing the first needle from the untreated intervertebral disc to create a partially treated intervertebral disc comprises removing the first needle twice, inserting of the second needle into the partially treated intervertebral disc at least one time comprises inserted the second needle twice, and the removing the second needle from the partially treated intervertebral disc comprising removing the needle twice inserting of the first needle into the untreated intervertebral disc of the subject at least one time or the inserting of the second needle into the partially treated intervertebral disc at least one time comprises inserting the first needle or the secondo needle inserting of the first needle into the untreated intervertebral disc of the subject at least one time or the inserting of the second needle into the partially treated intervertebral disc at least one time comprises inserting the first needle or the second needle a nucleus pulposus of the intervertebral disc at least one time”1.
Claims 4 and 5 are rejected due to their dependence on claim 3.
Re claim 9, line 2 refers to “the needle lumen”. However, this phrase lacks proper antecedent basis because claim 8 (upon which claim 9 depends) sets forth that both the first needle and the second needle comprise “a lumen” and it is unclear as to whether “the needle lumen” of claim 9 refers to the “lumen” of the first needle, the “lumen” of the second needle” or to the “lumen” of both needles. For the sake of examination, “the needle lumen” of claim 9 is interpreted as referring to the “lumen” of both needles. Accordingly, it is suggested to amend claim 9 to recite “the needle lumen of the first needle and of the second needle.
Claim 10 is rejected due to its dependence on claim 9.
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, 2, 8-10 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeung et al. (PG PUB 2013/0289599).
Re claim 1, Yeung discloses a method for treating an intervertebral disc in a subject (Para 215, “expedite disc 100 regeneration and pain relief”), comprising: inserting a first needle 102 (Fig 16; “spinal needle”, Para 12) into an untreated intervertebral disc of the subject at least one time (as seen in Fig 16; “needle 102 is advanced into the painful disc 100”, Para 196), removing the first needle from the untreated intervertebral disc to create a partially treated intervertebral disc (“withdrawal of the spinal needle 102”, Para 196), inserting a second needle 460 (Fig 43; “thin spinal needle”, Para 68) into the partially treated intervertebral disc at least one time (as seen in Fig 43; Para 215), removing the second needle from the partially treated intervertebral disc (inherent as the needle would not be in the body forever), and thereby treating the intervertebral disc to create a treated intervertebral disc (Para 215, “expedite disc 100 regeneration and pain relief”).
Re claim 2, Yeung discloses that inserting the first needle and the second needle is a period of greater than 7 days (since Para 196 discloses that the first needle 102 is removed prior to delivery the shunt 126 and Para 252 discloses that the second needle 460 can be used to seed donor cells 277 onto the shunt 126 “weeks, months or even years after implanting the disc shunts 126).
Re claim 8, Yeung discloses that the first needle and the second needle are hollow (since needle 102 receives guidewire 103 therethrough, as seen in Fig 17, Para 196 and needle 460 injects fluid therethrough, as seen in Fig 43, Para 215) and comprises a lumen for delivery of one or more fluids (as written, the claim only requires the lumen be capable of delivering fluids; since needle 102 can deliver a solid guidewire, it can deliver fluids and Para 215 discloses needle 460 delivering fluids).
Re claim 9, Yeung discloses that a fluid composition is delivered through the needle lumen into the nucleus pulposus of the subject (“cells 277 and nutrients/oxygen/pH buffer 131”, Para 215).
Re claim 10, Yeung discloses that the composition comprises cell composition comprising one or more of a compound, a nutrient, and a cell (“cells 277 and nutrients/oxygen/pH buffer 131”, Para 215).
Re claim 20, Yeung discloses a method for increasing intervertebral disc height in a subject (Para 214,215), comprising: inserting a first needle 102 (Fig 16; “spinal needle”, Para 12) into an untreated intervertebral disc of the subject at least one time (as seen in Fig 16; “needle 102 is advanced into the painful disc 100”, Para 196), removing the first needle from the untreated intervertebral disc to create a partially treated intervertebral disc (“withdrawal of the spinal needle 102”, Para 196), wherein the needle is inserted into the nucleus pulposus at least one time (as seen in Fig 16; Para 196); waiting a duration of greater than 14 days (Para 252, “injected […] weeks, months or even years”); inserting a second needle 460 (Fig 43; “thin spinal needle”, Para 68) into the partially treated intervertebral disc at least one time (as seen in Fig 43; Para 215); removing the second needle from the partially treated intervertebral disc (inherent as the needle would not be in the body forever), wherein the needle is inserted into the nucleus pulposus at least one time (as seen in Fig 43; Para 215); waiting a duration of greater than 7 days (Para 213, “3, 6, 12 and 24 months”) and thereby increasing the intervertebral disc height of the treated intervertebral disc (Para 214,215).
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 3, 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung et al. (PG PUB 2013/0289599) in view of Trieu (PG PUB 2007/0150060).
Re claim 3, Yeung discloses all the claimed features except explicitly disclosing that the first needle is inserted and removed twice from the untreated intervertebral disc and the second needle is inserted and removed twice from the partially treated intervertebral disc. Trieu, however, teaches performing a method to augment and treat an intervertebral disc multiple times (Para 83, wherein the term “multiple” requires two or more) for the purpose of treating discs that are in need of additional augmentation or treatment due to additional degeneration over time (Para 83). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Yeung to include performing the entire method (which would include insertion and removal of both of the needles) at least twice, as taught by Trieu, for the purpose of treating the disc if it is in need of additional augmentation or treatment due to additional degeneration over time (Para 83).
Re claim 4, Yeung discloses that the first or second needle has a gauge between about 18g and 30g (Para 198, wherein the first needle 102 has an OD of 1.27 mm (which is equal to 18g) and the second needle 460 has an OD of 0.51 mm (which is equal to 25g)).
Re claim 11, Yeung discloses that the first needle or second needle is solid (they both are solid as they are not liquid or gas).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung et al. (PG PUB 2013/0289599)/Trieu (PG PUB 2007/0150060) in view of Czaplewski et al. (PG PUB 2020/0352952).
Re claim 5, Yeung/Trieu disclose all the claimed features except explicitly disclosing that the first or second needle has a length between about 10 mm and 100 mm. Czaplewski, however, teaches that a needle that is 4.69 inches (119 mm, which one of ordinary skill in the art would consider “about” 100 mm) long is adequate to reach the middle of the nucleus pulposus (Para 119). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the first or second needles of Yeung to have a length 4.69 inches, as taught by Czaplewski, for the purpose of being adequate to reach the middle of the nucleus pulposus (Para 119).
Re claim 6, Yeung discloses that the first or second needle is inserted into the intervertebral disc at least 2 mm (since Yeung discloses that the nucleus pulposus is reached by both needles via insertion through the annulus fibrosus (as seen in Fig 16,43) and the annulus fibrosus is known to be composed of 15-25 concentric lamellae that each have a thickness of approximately 0.14 – 0.52 mm2, the needles must be inserted into the disc at least 2 mm to reach the nucleus pulposus).
Re claim 7, Yeung discloses that the first or second needle is inserted into the nucleus pulposus 128 (Fig 16, Para 39) at least one time (as seen in Fig 16 for the first needle 102 and Fig 43 for the second needle 460).
Claim 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung et al. (PG PUB 2013/0289599) in view of Trieu et al. (PG PUB 2005/0119754).
Re claim 12, Yeung discloses that the treated intervertebral disc has a disc height larger than the untreated disc (Para 214, “elevate, raise, lift, increase or sustain disc height as indicated by arrows in Figs. 40-41”) but does not explicitly disclose how much larger the height it; therefore, Yeung does not disclose that the height of the treated intervertebral disc is at least 105% the height of the untreated disc. Trieu, however, teaches treating an intervertebral disc such that its height after treatment is 146% of the height of the disc before treatment (Para 95) for the purpose of returning the disc to its sufficient height to counteract the effects of degeneration due to aging (Para 11). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Yeung to include the injection such that it causes the treated intervertebral disc to have a height that is 146% of the height of the untreated disc, as taught by Trieu, for the purpose of returning the disc to sufficient height to counteract the effects of degeneration due to aging (Para 11).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yeung et al. (PG PUB 2013/0289599)/Trieu (PG PUB 2007/0150060)/Czaplewski et al. (PG PUB 2020/0352952) in view of Trieu (PG PUB 2005/0119754).
Re claim 13, Yeung discloses that the treated intervertebral disc has a disc height larger than the untreated disc (Para 214, “elevate, raise, lift, increase or sustain disc height as indicated by arrows in Figs. 40-41”) but does not explicitly disclose how much larger the height it; therefore, Yeung/Trieu ‘060/Czaplewski does not disclose that the height of the treated intervertebral disc is between 105% and 200% the height of the untreated disc. Trieu ‘754, however, teaches treating an intervertebral disc such that its height after treatment is 146% of the height of the disc before treatment (Para 95) for the purpose of returning the disc to its sufficient height to counteract the effects of degeneration due to aging (Para 11). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Yeung/Trieu ‘060/Czaplewski to include the injection such that it causes the treated intervertebral disc to have a height that is 146% of the height of the untreated disc, as taught by Trieu ‘754, for the purpose of returning the disc to sufficient height to counteract the effects of degeneration due to aging (Para 11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2007/0255406 to Trieu (having needles 32,42), PG PUB 2007/0173943 to Dulak (having needles 52,90) and PG PUB 2005/0209699 to Slivka et al. (having needles in Para 103,104) each disclose a method for treating an intervertebral disk by inserting and removing a first needle and then inserting and removing a second needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 It is noted that this suggested amendment also incorporates the suggested amendments to overcome the objection of claim 7 set forth above.
2 Alonso et al. Encyclopedia of the Neurological Sciences (Second Edition), 2014. Pages 724-729.