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 1 has been amended.
Claims 1, 3-5, 7-8, 10-14, 16-18, 102 and 104-107 are pending.
Claims 2, 6, 9, 15, 19-101, 103 and 108-111 are cancelled.
Claims 102 and 104-107 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/06/2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 5, 10, 13, 14, and 18 are rejected under 35 U.S.C. 103 as being taught by MURAKAMI (Hyaluronic gel injection into the vesicovaginal septum for high-dose-rate brachytherapy of uterine cervical cancer: an effective approach for bladder dose reduction. Clinical Investigations. 2/28/2019) in view of KEIJZER (The filter of choice: filtration method preference among injecting drug users. Harm Reduction Journal. 2011.).
Regarding claim 1, MURAKAMI teaches a method of tissue spacing for radiotherapy (Page 2, paragraph 1) to limit exposure to the immediate adjacent organs at risk (page 1, purpose). The method comprises a hyaluronic acid gel injection, which reads on bioabsorbable viscoelastic medium. A contrast agent is added, which reads on visualization additive (Page 2 right column). The injection was into the site of radiotherapy (Page 2 right column). The method produced clear ultrasound images (figure 1), which reads on “an amount sufficient to generate contrast between the viscoelastic medium and the site of the radiotherapy”.
Regarding claim 5, MURAKAMI teaches 5 to 10 mL was injected into the site (Page 3, right column).
Regarding claim 10, The prior art’s method would have the same physical/chemical properties as claim by Applicant, such as “migration of the viscoelastic medium is prevented or decreased upon injection of the composition relative to a reference migration of a control composition”, because the prior art’s method has the same active steps and composition as claimed by Applicant.
Regarding claim 13, MURAKAMI teaches the composition reduced dosage by 21% with injection. The median bladder dosage without injection 569 cGy vs 449 cGy dosage with injection, (Page 5, paragraph 1).
Regarding claim 14, MURAKAMI teaches the composition is used for radiotherapy of uterine cervical carcinoma, which reads on cervix (page 1, paragraph 2).
Regarding claim 18, MURAKAMI teaches the site of radiotherapy was imaged (Page 3, right column and figure 3).
MURAKAMI does not teach passing the bioabsorbable viscoelastic medium through a protrusion.
KEIJZER teaches that syringes with filters inside them are designed to prevent complications with the injection of drugs (abstract). The small pore size can reduce the solution's insoluble particle content (abstract).The filters with small pore sizes read on mesh and the attachment reads on protrusion.
Note Applicant’s specification states that the needle can comprise a protrusion (Applicant’s specification page 53, paragraph 0144). Therefor the protrusion and mesh added by KEIJZER would be considered part of the needle and therefor part of the interior surface of the needle. A protrusion is defined as “a physical state of something projecting outward beyond a surface or normal line”, which the filter added in KEIJZER reads on.
Note, since the prior art has the same components (i.e the same composition, location injected, amount injected, and a protrusion/mesh) it would have the same inherent properties, such as where “passing the bioabsorbable viscoelastic medium through the protrusion or mesh would form microbubbles”.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a filter for a syringe. The person of ordinary skill in the art would have been motivated to make those modifications, because it prevents complications with the injections of drugs, and reasonably would have expected success because the references are in the same field of endeavor, such as the injection of drugs.
Claims 1, 3-5, 7, 10, 13, 14, and 18 are rejected under 35 U.S.C. 103 as being taught by MURAKAMI (Hyaluronic gel injection into the vesicovaginal septum for high-dose-rate brachytherapy of uterine cervical cancer: an effective approach for bladder dose reduction. Clinical Investigations. 2/28/2019) and KEIJZER (The filter of choice: filtration method preference among injecting drug users. Harm Reduction Journal. 2011.) in view of CHEN ( US 2015/0328123 A1).
MURAKAMI and KEIJZER teach Applicant’s invention as discussed above.
MURAKAMI and KEIJZER do not teach using gel particles.
Regarding claims 3 and 4, CHEN teaches a tissue filler (abstract) that is comprised of hyaluronate gel particles (Page 2 paragraph 0013). The particles allowed for easy injection into the site (Table 2). Cytotoxicity, a measurement of a composition’s ability or lack thereof to damage or kill cells, test was performed on the hyaluronic acid gel (page 4, paragraph 0037).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate gel particles. The person of ordinary skill in the art would have been motivated to make those modifications, to create a composition that is easily injected into the required site and reasonably would have expected success because both references deal with injectable hyaluronic acid gel.
Regarding claim 7, the references do not specifically teach the concentration of hyaluronic acid as claimed by the Applicant. The concentration of hyaluronic acid is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal concentration of hyaluronic acid in order to best achieve desired results, such easy of injection and/or as having a concentration of hyaluronic acid that does not produce cytotoxicity and harm the patient. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of concentration of hyaluronic acid would have been obvious at the time of Applicant’s invention.
Claims 1, 3-5, 7, 8, 10-14, and 18 are rejected under 35 U.S.C. 103 as being taught by MURAKAMI (Hyaluronic gel injection into the vesicovaginal septum for high-dose-rate brachytherapy of uterine cervical cancer: an effective approach for bladder dose reduction. Clinical Investigations. 2/28/2019), KEIJZER (The filter of choice: filtration method preference among injecting drug users. Harm Reduction Journal. 2011.) and CHEN ( US 2015/0328123 A1) in view of LIM (MICROSCOPIC GOLD PARTICLE-BASED FIDUCIAL MARKERS FOR PROTON THERAPY OF PROSTATE CANCER. Physics Contribution. 2009).
MURAKAMI, KEIJZER and CHEN teach Applicant’s invention above.
MURAKAMI, KEIJZER and CHEN do not teach the size of the particles used or a precious metal for the visualization additive.
Regarding claims 8, 11 and 12, LIM teaches gold, which reads on precious metal, nanoparticles for prostate cancer imaging (abstract). The gold particles were mixed with a silicone paste and had a dimeter size of 1.2 to 3.0 mm. The gold nanoparticles showed good radiographic visibility, low distortion of the depth-dose distribution, and few CT artifacts (abstract and page 1610 paragraph 2).
Additional disclosures: the nanoparticles showed no migration during treatment (Page 1609, right column).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using particles with a dimeter of 1.2 to 3.0 mm. The person of ordinary skill in the art would have been motivated to make those modifications, because the size allowed for fewer CT artifacts, and reasonably would have expected success because MURAKAMI and Lim are in the same field of endeavor, such as imaging cancer therapy.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using gold for the visualization additive. The person of ordinary skill in the art would have been motivated to make those modifications, because gold allowed for good radiographic visibility, low distortion of the depth-dose distribution, and few CT artifacts and reasonably would have expected success because MURAKAMI and LIM are in the same field of endeavor, such as imaging cancer therapy.
Claims 1, 3-5, 7, 8, 10-14, and 16-18 are rejected under 35 U.S.C. 103 as being taught by MURAKAMI (Hyaluronic gel injection into the vesicovaginal septum for high-dose-rate brachytherapy of uterine cervical cancer: an effective approach for bladder dose reduction. Clinical Investigations. 2/28/2019), KEIJZER (The filter of choice: filtration method preference among injecting drug users. Harm Reduction Journal. 2011.), CHEN ( US 2015/0328123 A1) and LIM (MICROSCOPIC GOLD PARTICLE-BASED FIDUCIAL MARKERS FOR PROTON THERAPY OF PROSTATE CANCER. Physics Contribution. 2009) in view of HIRSCH (Hyaluronidase in the office: A necessity for every dermasurgeon that injects hyaluronic acid. Informa healthcare. 2007).
MURAKAMI, KEIJZER, CHEN and LIM teach the Applicant’s invention above.
MURAKAMI, KEIJZER, CHEN and LIM do not teach injecting hyaluronidase 0.1 hours to 24 hours after injection of the viscoelastic medium or reducing the volume of viscoelastic medium from an original volume.
Regarding claim 17, HIRSCH teaches that hyaluronidase is commonly used for complication with hyaluronic filler complications (Page 182, paragraph 2). HIRSCH teaches that a patient who showed severe complication after a hyaluronic acid embolic event was given hyaluronidase 6 hours after injection (Page 184, Injection necrosis). HIRSCH teaches that if an excess of filler is given hyaluronidase is used to reduce the size of said filler to prevent or decrease complications, such as a cosmetic defect (Page 183, Excessive Product). The method described above reduces the excessive material injected (Page 183, Excessive Product).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate injecting hyaluronidase 6 hours after injection of the viscoelastic medium to reduce the volume of filler present. The person of ordinary skill in the art would have been motivated to make those modifications, to treat any complications, such as an excessive amount was added and is causing a cosmetic defect with the hyaluronic acid injection as soon as it appears, and reasonably would have expected success because it is the commonly used treatment for issues with hyaluronic acid injection complications and MURAKAMI, CHEN and HIRSCH all deal with the same field of endeavor, such as hyaluronic acid injections for tissue spacing or fillers.
Regarding claim 16, The reference does not specifically teach the percentage range of reduction of filler, as claimed by the Applicant. The percentage of reduction is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal percentage of reduction in order to best achieve desired results, such as reducing the correct amount to resolve any complications or reducing to a proper amount of material injected. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of percentage of reduction would have been obvious at the time of Applicant’s invention.
Response to Arguments
Applicant argues, The filters of Keijzer are not in "a needle whose interior surface comprises one or more of a protrusion, a mesh, or a constriction," but rather are in line with the needle or in a syringe, as stated in the Applicant's response filed December 3, 2025, which - for the sake of brevity - is hereby incorporated by reference herein in its entirety. Therefore, Keijzer fails to cure the disclosure deficiencies of Murakami.
The Examiner does not find the argument persuasive because as discussed above, Note Applicant’s specification states that the needle can comprise a protrusion (Applicant’s specification page 53, paragraph 0144). Therefor the protrusion and mesh added by KEIJZER would be considered part of the needle and therefor part of the interior surface of the needle. A protrusion is defined as “a physical state of something projecting outward beyond a surface or normal line”, which the filter added in KEIJZER reads on.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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