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 .
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.
Election/Restrictions.
Examiner is maintaining 103 rejection made in the Non-Final-Office action of 06/24/2025.
Examiner did not find prior art on applicants elected species therefore Markush Search was extended to full scope of independent claim 1.
Claims 1-4, 6-14, 16-17, and 19 are examined.
Current Status of 17/294,143
This office action is in response to the amended claims on September 24th 2025.
Claims 1, 12 and 16 are currently amended; and claims 2-4, 6-14, and 17are previously presented; and claims 19 are new.
Claims 1-4, 6-14, 16-17 and 19 are examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has claimed priority to foreign priority DE 102018128822 of 11/16/18.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of September 24th 2025.Examiner have reviewed these remarks and amendments.
Applicants’ revisions permit Examiner to withdraw the objection of record.
Regarding 103 rejections,
applicant amended claim 1, 12 and 16 to incorporate the limitation “stiffening the collagenous tissue of the joint by at least 52%.”
Applicant argues
Applicant claims surprising and unexpected results. In applicant remarks on page 13 in last paragraph, applicant state, “Prior to the present application no one has ever suggested the use of riboflavin for strengthening the native collagen fibers of joints, such as invertebrate disk, particularly by stiffening the collagenous tissue of the joint by at least 52%.”
However, the specification supports this claim as follows: “The iminium stiffening or reinforcement is 52%, while the maximum stiffening is 348%.” (page 30 line 9).
Examiner’s response:
Applicant claim of criticality based on “reinforcement is 52%, while the maximum stiffening is 348%” is regarded as attorney’s opinion therefore is not persuasive. The specification does not show any data to support applicant’s claim of criticality. Therefore 103 rejection is maintained
To advance prosecution and expedite allowance, applicants is/are encouraged to file affidavit showing surprising and unexpected results. Mere attorney opinion without the affidavit or explicit support in the Specification does not constitute evidence of secondary considerations.
Claim Objections (new)
Claim 16 is objected to for using language of a method claim “stiffening the collagenous tissue of the joint by at least 52%”. Applicant is encouraged to rewrite this portion of the kit/composition of matter claim to: -- wherein the collagenous tissue of the joint is stiffened by at least 52%. -- .
.
Claim Rejections - 35 USC § 103 (maintained with modification)
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 1-4, 6-14, 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over
Schmocker et. al (US 20170274218 A1).
In view of
Jester et. al (US 2013/338650 Al).
In further view of
Meek et.al.; PLoS ONE, August 2011, Volume 6, Issue 8, page 22405
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
Determining the scope and contents of the prior art.
Schmocker et. al. teaches riboflavin as a medication for treating a patient having a disorder of the joint (examiner interpret this as any joint, including invertebrate disc, diarthrotic, amphiarthrotic, synarthrotic joints) (paragraphs [0021], [0022] and [0025]) (claims 1, 12, 4), wherein the treatment occurs in-situ in the patient (paragraph [0021]) and comprises local administration with injection system [0011] of riboflavin in a collagen-rich tissue of the joints ( since prior art is silent about where in the joint the composition is administered, examiner interpret this to include annulus fibrosus and nucleus pulposus teaching claims 17) (paragraph [0021]) and subsequent irradiation with electromagnetic radiation (paragraph [0022]). Schmocker teaches the composition as a device or kit with riboflavin, teaching claim 16 (abstract).
The limitation “instructions for the treatment of a patient…exposure to radiation…” (last 3 lines of claim 16) constitute non-functional printed matter. Non-functional printed matter does not distinguish claimed product from otherwise identical prior art product. See MPEP 2112.01(III).
Schmocker et. al. also teaches the use of UV light [0040] (claim 2,), wavelength in the range 200-3000[0009] (claim 6, 7-8) which is within the range greater than 700nm wavelength [0042](claim 3).
Jester et.al teaches pulse radiation methods of using nonlinear optical (NLO), femtosecond-near infrared lasers to activate photosensitizing chemicals such as riboflavin in a 20% dextran solution(examiner is interpreting this as pharmaceutical carrier in liquid form) (paragraph [0050]) to generate free radicals leading to collagen crosslinking (CXL) (examiner is interpreting this as stiffening of collagenous tissue) and corneal stiffening (claims 1, 7-10, 12, 16 and 19) [007] [0044].
Meek et. al teaches use of hypo-osmolar riboflavin/UVA cross-linking of collagen resulted in an increased tissue hydration (claim 13-14) (pg 3).
Anisel et.al. teaches dosage and concentration of pharmaceuticals administer to patients as routine optimization (page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Although, Schmocker et. al (US 20170274218 A1), teaches claims 1-4, 7, 12, 16-17 and 19 see above. Schmocker does not teach the use of nonlinear optical pulse irradiation to activate riboflavin or stiffening of collagenous tissue.
Although, Jester et.al teaches pulse radiation methods of using nonlinear optical
(NLO), femtosecond-near infrared lasers to activate photosensitizing chemical such as riboflavin to generate free radicals leading to collagen crosslinking (CXL)(examiner is interpreting this as stiffening of collagenous tissue, ) and corneal stiffening (claims 1,7-10, 16 and 19) [007][0044]. Jester et.al does not teach the use of riboflavin in treating invertebrate disc disease in diarthrotic, amphiarthrotic and synarthrotic joints.
Meek et. al teaches use of hypo-osmolar riboflavin/UVA cross-linking of collagen resulted in an increased tissue hydration (claim 13-14) (pg 3). Meek et.al does not teach the use of riboflavin in treating invertebrate disc disease in diarthrotic, amphiarthrotic and synarthrotic joints.
Anisel et.al. does not teach treating invertebrate disc disease.
Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for invertebrate disc diseases and is looking into optimizing radiation method for treating invertebrate disc of the joint without affecting surrounding tissue.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
It is known in the prior art that riboflavin is injected into joints as sensitizer to induce polymerization of collagens using electromagnetic irradiation (Schmocker et. al to treat joint disorder [0011],[0021],[0022] and [0025]). Artisan skilled in the art would be motivated to use hypo-osmolar solution of riboflavin to keep joint tissue hydrated to (claims 13-14) (Meek et. al pg 3) to induce polymerization of collagen in joint to treat joint disorder (Schmocker et. al [0011],[0021],[0022] and [0025]). Moreover, artisan skilled in the art would be motivated to use pulse radiation methods of using nonlinear optical (NLO), femtosecond-near infrared lasers to activate photosensitizing chemicals such as riboflavin to generate free radicals to minimize the side effect to the surrounding joint tissue to crosslink collagen (CXL) (Jester et.al. [007][0044]) ) (claims 1,7-10, 16 and 19) to treat invertebrate joint (since invertebrate joint also have collagen) disease such as disease in diarthrotic, amphiarthrotic or synarthrotic joints. Therefore, it would be expected injecting hypo-osmolar solution of riboflavin (Meek et. al pg 3) in diarthrotic, amphiarthrotic or synarthrotic joints; followed by nonlinear optical (NLO), femtosecond-near infrared lasers irradiation) (Jester et.al. [007][0044]) ) will result in crosslinking of collagen, thus stiffening collagenous tissue in the joint thus (claims 1,7-10, 16 and 19), thereby treating diseases of diarthrotic, amphiarthrotic or synarthrotic joints, since the same cross-linking would be expected to occur in these joints as has been demonstrated in other joints (see, above). Thus teaching claims 1,7-10,12, 16-17 and 19).
Therefore, it is prima facie obvious to combine the teaching of Schmocker et. al (US 20170274218 A1) with the teaching of Jester et. al (US 2013/338650 Al) and the teaching of Meek et.al. (PLoS ONE, August 2011, Volume 6, Issue 8, e22405)
to treat invertebrate joint disease to precisely target affected disc for the reasoning, above. Thus, teaching independent claims 1 and 16.
Claims 1,3,6-11, 13-14 and 16 are drawn to attributes examiner interprets as variables the artisan would normally be expected to routinely optimize. Applicants’ claims or specification do not indicate critically of these attributes. Generally, differences impurities, percentage conversion or reaction temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. “[W]here 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claims 3 and 6-11 are drawn wavelength, energy input, output of electromagnetic irradiation and duration of the radiation. It would be obvious for a person skilled in the art to optimize these attributes to arrive at the desired stiffening of the collogen tissues at the joint.
Claims 13-14 are drawn hypo-osmolar solution and the claimed concentration fall within the scope of a normal standard procedure implemented by a person skilled in the field of pharmaceuticals. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50).
Claim 1, and 16 are drawn to at least 52% stiffening of collagenous tissue of the joint. The specification does not show any data to support applicant’s claim of criticality. There is no evidence in the specification that shows 52% stiffening of collagen tissue advantageous.
To advance prosecution, applicants is/are encouraged to file affidavit that shows evidence of surprising and unexpected results.
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).
Conclusion
Claims 1-4, 6-14, 16-17 and 19 are not allowable as written.
To advance prosecution, applicants is/are encouraged to file affidavit that shows evidence of surprising and unexpected results.
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 Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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, Andrew D Kosar can be reached at (571)272-913. 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.
/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625