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 .
Receipt is acknowledged of IDS filed on 10/29//2025.
Claims 1, 3-5, 7, 8, 10-14, 16-18, 102, 104-107, and 110-111 are pending.
Claims 2, 6, 9, 15, 19-101, 103 and 108-109 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Claims 102 and 104-107 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 102
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 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, 5, 10, 13, 14, 18 and 111 are rejected under 35 U.S.C. 102(a)(1) as being anticipated 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).
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”.
Additional Disclosure: 5 to 10 mL was injected into the site (Page 3, right column); used for radiotherapy of uterine cervical carcinoma, which reads on cervix (page 1, paragraph 2); reduced dosage by 21% with injection, median bladder dosage without injection 569 cGy vs 449 cGy dosage with injection, (Page 5, paragraph 1), which reads on dose of the radiotherapy contacting the tissue proximate to the site of radiotherapy is reduced by about 10% to about 80% compared to a patient that did not receive an injection; the site of radiotherapy was imaged (Page 3, right column and figure 3). A 19 G puncture needle was used to inject (Page 3, paragraph 1).
Regarding Applicant’s recitation of “the bioabsorbable viscoelastic medium comprises a plurality of microbubbles formed upon injecting the bioabsorbable viscoelastic medium at the site of the radiotherapy”. It would be inherent that the method in MURAKAMI would have the same inherent ability since it has the same components and steps.
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.
Note for claim 111, since all needles have a geometry and the specification says that a 19 G needle can be used (Example 1, paragraph 1), it would be inherent that the geometry of the needle being used in the reference would create microbubbles upon injection.
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. 18, 110 and 111 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.).
MURAKAMI teaches Applicant’s invention as discussed above.
MURAKAMI does not teach passing the bioabsorbable viscoelastic medium through a mesh inserted into a needle.
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.
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. 18, 110 and 111 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.
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.
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, 18, 110 and 111 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.
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, 16-18, 110 and 111 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.
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.
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 Office is ignoring the Applicant's disclosure that describes in detail the features of the needle that can create "a plurality of microbubbles formed upon injecting the bioabsorbable viscoelastic medium at the site of the radiotherapy," as recited by claim 1.
[0179] In some embodiments, an interior surface of the needle comprises a protrusion, a mesh, a constriction, or any combination thereof. In some embodiments, injecting the spacing material past the protrusion, the mesh, the constriction, or any combination thereof produces a gas bubble in the spacing material. In some embodiments, the gas bubble is a microbubble.
Murakami and the other art (cited in the various § 103 rejections) are silent as to these disclosed structures on "an interior surface of the needle." Thus, Murakami's bare disclosure of the 19 G diameter of the needle is insufficient to inherently or explicitly disclose the elements of independent claim 1. As such, the claim is patentable over Murakami. Withdrawn claim 102 includes similar elements and is similarly allowable.
The Examiner finds Applicant’s argument unpersuasive, because in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a protrusion, a mesh, a constriction, or any combination thereof inside of the needle) are not recited in the rejected claim 1. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues, Claim 110 recites "wherein the microbubbles are created upon injection by passing the bioabsorbable viscoelastic medium through a mesh inserted into a needle." ( emphasis added). The Office's analysis of Keijzer is incorrect for at least two reasons. First, the disclosed filters do not fit inside a syringe, as the Office states. Keijzer discloses three types of filters "Three IDUSF are currently available: the Compet AG syringe filter (Compet AG, Switzerland), the "filter syringe" (Frontier Medical Group, UK) and the Sterifilt@ (Apothicom, France)." Keijzer at 1-2.
Second, even if the filters did fit inside a syringe, this is not what claim 110 recites. The filters disclosed by Keizjer either fit over the needle or in line with the needle coupled via a luer hub, not "inserted into a needle," as recited by claim 110. Claim 110 does not recite that a filter fits inside a syringe, but rather that "a mesh inserted into a needle." As is well known in the medical arts, a needle and a syringe are in fact two distinct and separate items. Needles are coupled to a syringe by a luer hub and are fed with a fluid from the syringe.
While Keijzer does not show images of these filters, a simple internet search yields the following results showing the filters from Apothicom and Com pet. The Frontier Medical Group filter could not be located.
PNG
media_image1.png
345
738
media_image1.png
Greyscale
Exh. 2 shows the Com pet Medical filter clearly fitting in line with a needle, not "inserted into a needle," as recited in claim 110. Keijzer thus fails to cure the disclosure deficiencies of Murakami with respect to claims 1 and 110.
This argument is not found persuasive because, the Examiner interpreted Applicant’s claim 110 reasonably broad and without creating any 112 issues. However, Applicant’s interpretation/explanation would create 112 issues, as failing to comply with the written description requirement and enablement, such as the claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or at the time the application was filed, had possession of the claimed invention. In this instance, Applicant’s specification only has a single paragraph stating “an interior surface of the needle comprises a protrusion, a mesh, a constriction, or any combination thereof. In some embodiments, injecting the spacing material past the protrusion, the mesh, the constriction, or any combination thereof produces a gas bubble in the spacing material. In some embodiments, the gas bubble is a microbubble. In some embodiments, the mesh has a mesh spacing of about 20 μm to about 300 μm. In some embodiments, a size of the mesh spacing determines a size of the microbubbles produced thereby” (see Applicant’s specification at page 53, paragraph 0144). However, Applicant provided no diagrams or additional disclosures on how to make this mesh inside the needle. Additionally, Applicant provided no disclosure if this mesh needle is commercially available.
Furthermore, as evidenced by AIJIREN (How to Prevent Air Bubbles When Using Syringe Filters? 6 Step. 2025.) syringe filters often inherently cause air bubbles to form for various reasons (paragraph 1). It is unclear how a filter inside the needle would cause bubbles and a filter in line with a needle would not, especially since syringe filters often inherently cause bubbles to form.
Lastly, it is unclear how a 300 micron mesh could fit inside of a 19 G diameter needle. A 19 G diameter, is roughly 650 microns. If the mesh was inside this diameter only 2 holes would be present and the needle would have a high chance of clogging. It appears physically impossible. The only logical interpretation would be a mesh in the leu hub, as shown in Exh. 2, the Com pet Medical filter, as disclosed by Keizjer, and not in the needle as defined by Applicant, especially without a diagram or description to explain how a 300 micron spaced mesh would fit inside of a roughly 600 microns diameter.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL HARTLEY can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618