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 .
DETAILED ACTION
Claim Status
The amended claim set of 17 Jul 2023 has been entered and reviewed.
Claims 1-10 have been amended.
Claims 11-22 are new.
Claims 1-22 are pending and under consideration.
Election/Restrictions
Applicant’s election of “wrist to fingertips” as the administration site and “Heberden’s nodule” as the pain in the reply filed on 20 Jan 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-5, 7, 12-18, and 20-22 are withdrawn from further consideration by the examiner, pursuant to 37 CFR 1.142(b), as being drawn to a non-elected species.
Claims 1, 2, 6, 8-11, and 19 are under consideration to the extent of the elected species, i.e., that the administration site is “wrist to fingertips” as the pain is Heberden’s nodule”.
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, 2, 6, 8-11, and 19 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 recites “an X-ray image of Roentgen.” This phrase is unclear. A Roentgen is a type of unit that may be used with x-ray imaging and it is not clear what is meant by producing an x-ray image of the unit. Claims 2, 6, 8-11, and 19 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 1.
Claims
Applicant is advised that should claim 2 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 6, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Okuno et al. (Journal of Vascular and Interventional Radiology, 2017, Pages 1-8, listed on IDS filed 17 Jul 2023) in view of New York Hand and Wrist (Osteoarthritis of the Hand, 03 Aug 2016).
Okuno teaches osteoarthritis is a common degenerative joint disease with a hallmark symptom of pain and that alleviation of pain is a main motivation for treatment (page 1). Okuno teaches that osteoarthritis is an inflammatory disease of synovial joints and that angiogenesis contributes to the inflammation (page 2 left column). Okuno teaches that the new increased vascular network provides inflammatory cells access to the synovium and other joint tissues and promotes additional hyperplasia and inflammation in other vessels and that angiogenesis contributes to chronic pain by enabling the growth of new unmyelinated sensory nerves (page 2 left column). Okuno teaches treatment of patients with knee osteoarthritis with transcatheter arterial embolization (page 2 left column) with 75μm Embozene microspheres (page 3 right column). Administration was done in through the femoral artery (page 2 right column) rendering it obvious to administer the embolic agent through an artery to the site of treatment. Administration included administering iodinated contrast medium for angiography (page 2 right column, page 3 left column) and the embolization endpoint was suppression or reduction in the filling of abnormal vessels visible on angiography (page 3 right column) where the catheter was removed after confirming successful reduction of the number of abnormal vessels on angiography (page 4 left column). Ending the embolization after confirming redaction of vessels with angiography renders obvious terminating the administration based on detection of embolic material at the pain site in an X-ray image. Okuno teaches that the treatment resulted in decreased pain (page 5 left column, page 6 left column).
Okuno does not teach the elected pain site of wrist to fingertips or the elected pain of Heberden’s nodule. These deficiencies are made up for in the teachings of New York Hand and Wrist.
New York Hand and Wrist teaches that arthritis can affect any joint in the body, including the bones of the wrist, hand and fingers and that osteoarthritis is a common form of hand arthritis (page 2). New York Hand and Wrist teaches that a common site for hand arthritis is at the joint closest to the fingertip (the distal interphalangeal joint) page 3). New York Hand and Wrist teaches that osteoarthritis may cause bony nodules at the end joint of the finger known as Heberden’s nodes (page 3, Fig 2). New York Hand and Wrist teaches that a goal of treatment is to relieve pain (page 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have treated pain from Heberden’s nodes in fingers with the embolic particle method of Okuno. Osteoarthritis pain is known from Okuno to be related to vascular angiogenesis and the pain may be reduced by treating the area with embolic particles by injection through an artery. Heberden’s nodes are bony nodules at the end joint of the finger whose cause is related to osteoarthritis and it is desirable to treat the associated pain, as known from New York Hand and Wrist. Thus, it would have been obvious to one of ordinary skill to extend the embolic particle method of Okuno to treatment of pain from Heberden’s nodes in fingers as Heberden’s nodes are linked to osteoarthritis and it would be desirable to treat the resulting pain. One would have a reasonable expectation of success as embolizing vasculature related to osteoarthritis in knees is known to reduce pain and it would be obvious to extend the same method for treatment of the same condition in an alternative location of the body.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Okuno et al. (Journal of Vascular and Interventional Radiology, 2017, Pages 1-8, listed on IDS filed 17 Jul 2023) in view of New York Hand and Wrist (Osteoarthritis of the Hand, 03 Aug 2016) as applied to claims 1, 2, 6, and 9-11 above and further in view of Mackay (J Appl Physiol, Sep 1955).
The teachings of Okuno and New York Hand and Wrist are described supra.
Okuno and New York Hand and Wrist do not teach positioning the blood flow of the affected area toward a direction of gravity rather than a horizontal plane. This deficiency is made up for in the teachings of Mackay.
Mackay teaches that raising the arm above the head causes drainage of a volume of blood by gravity from the limb vessels (page 169 right column). Mackay similarly teaches that blood can be drained from the legs by holding the patient in an angled head down position (page 170 right column) and drained from the hand by raising the arm above the head (page 171 Venous drainage from the hand).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to position the limb, such as the hand with Heberden’s nodes, in a downward position, in line with gravity. It is known from Mackay that blood flow responds to gravity and that when a limb is positioned upward that the blood will flow out of the limb. As the method rendered obvious by Okuno and New York Hand and Wrist involved injecting particles into arteries, it would be obvious that positioning the area of treatment in an upward position would lead to less blood flow to the area and thus less of the particles would reach the desired treatment location. As it is known that blood will flow out of a limb when positioned upward due to gravity, one of ordinary skill would recognize that blood would more readily flow into a limb when positioned downward due to gravity. As the treatment method relied on the delivery of particles for embolization, it would have been obvious to position the treatment area downward, in line with gravity, so that the blood may more easily flow into the area, thereby increasing the amount of embolic particles that get deposited to the desired area.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2 6, 8-11, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/041,415 in view of Okuno et al. (Journal of Vascular and Interventional Radiology, 2017, Pages 1-8, listed on IDS filed 17 Jul 2023), New York Hand and Wrist (Osteoarthritis of the Hand, 03 Aug 2016), and Mackay (J Appl Physiol, Sep 1955).
The ‘415 application claims a method of treatment for pain comprising administering a particulate embolic material with an average diameter of 10-200 μm and the agent is administered via a catheter distal to a branch of a spinal artery feeding a site of pain.
The ‘415 application does not claim terminating the administration based on detection of the embolic material with x-ray, that the pain is in the wrist to fingers from Heberdens node or positioning the treated area in a direction of gravity. These deficiencies are made up for in the teachings of Okuno, New York Hand and Wrist and Mackay.
The teachings of Okuno, New York Hand and Wrist and Mackay are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have ended the embolic administration after detection with xray imaging, and to have treated fingers suffering from Heberden’s nodes and to position the treatment area downward in the direction of gravity. A similar method of treating osteoarthritis pain with embolic particles is taught by Okuno where the administration includes a contrast medium for angiography and the embolization endpoint is determined when filling the vessels is visible with angiography. Thus, using xray imaging (angiography) is a known means of determining when to end embolization and would be obvious to apply to the method of the reference claims so the user would known when to end the procedure. The embolization method for treating pain is known from Okuno to treat osteoarthritis and finger pain from Heberden’s nodes are linked to osteoarthritis, as taught by New York Hand and Wrist, rendering it obvious to extend the embolic procedure to treatment of Heberden’s nodes in fingers. Further, it is known from Mackay that blood flow depends on the limb positioning with gravity, and it would be obvious to position the limb in a downward position with gravity so as to ease the blood flow in the direction of the desired treatment area.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600