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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/2025 has been entered.
Status of the Claims
Claims 1-3, 9 and 12-22 are pending in a response of 11/24/2025.
Withdrawn rejections:
Applicant's amendments and arguments filed 11/24/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
Claim Objection
Claims 13, 14, 21 and 22 are objected to minor informalities.
Each of claims 13-14 recites a group selected from … and any combinations thereof”, but which is not proper Markush format of “… selected from the group consisting of A, B and C”. In the alternative, format “chosen from A, B or C” can be used.
Claim 21 recites “hydrogel is formed” in lines 3 and 7, but which would be better to “the hydrogel is formed”.
Claim 22 recites “wherein the hydrogel forming polymer having an intrinsic viscosity …”, but which would be better to write “wherein the hydrogel forming polymer has an intrinsic viscosity …”.
Appropriate correction is requested.
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 1-3, 9 and 12-22 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.
In claim 1, two contradictory limitations are present: 1) “the hydrogel forming polymer comprises a derivative modified with one or modification …” in lines 6-7 and 2) “the hydrogel forming polymer is selected from the group consisting of a hyaluronic acid, a derivative thereof, and any combinations thereof” in the last first-second lines. That is, due to “comprising” language, underivatized polymer could be added but the hydrogel forming polymer always requires its derivatives according to 1). On the other hand, the Markush group format 2) seems to say that unmodified can be used for the hydrogel forming polymer. That is it is not clear how unmodified “hyaluronic acid” in the last line can be a candidate for the hydrogel forming polymer.
Further, claim 1 recites “the hydrogel is obtained by the hydrogel forming polymers” in line 10. If so, “hydrogel forming polymer” in claim 1 should have changed to “at least two hydrogel forming polymers”? As a result, claim 1 is indefinite.
Claim 9 recites “said hydrogel forming polymer is a first polymer and the composition further comprises a second polymer derivative …” It is not clear whether the second polymer derivative is hydrogel forming polymer or not because according to claim 1, the hydrogel is obtained by the hydrogel forming polymers.
Claim 9 also recites “said first polymer derivative” in lines 7, 9, 11 and 13 which lacks sufficient antecedent basis because line 2 of claim 9 recites “a first polymer”, instead of “a first polymer derivative”.
Claim 21 recites “said one or more hydrogel forming polymers”, but which lacks sufficient antecedent basis because base claim 1 does not recite “one or more hydrogel forming polymers”.
The remaining claims are also rejected due to the rejection of base claim 1.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-3, 9 and 12-22 are rejected under 35 USC 103 as being obvious over Gravett et al. (US2014/0328926A1) in view of Yoneto (US2019/0262259A1, earliest international filing date: 2017-07-25) and Kakinoki et al. (WO2000/056344A1, citation is obtained from Google English translation).
Applicant claims including the below claim 1 filed on 11/24/2025:
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Determination of the scope and content of the prior art
(MPEP 2141.01)
Gravett teaches modified hyaluronic acid polymer compositions and related methods (title); the compositions comprise hydrophilic and water soluble hydrogel formed by reaction of a hyaluronic acid derivatives having divinyl sulfone which reads on the claimed first polymer derivatives having vinyl sulfone with thiol-functionalized hyaluronic acid which reads on the claimed second polymer having thiol and a crosslinker having thiol group such as PEG dithiol; hyaluronic acid aqueous solution is added to the hydrogel in an amount of about 0.3% (=3mg/ml) to about 4% (=40mg/ml) ([0132]) or from about 0.5% (=5mg/ml) to about 2% (=20mg/ml) or at least 0.1mg/ml ([0134]), and final hyaluronic acid content in the gel composition is about 0.05 to 5% (=0.5mg/ml to 50mg/ml) ([0132]) which overlaps the claimed range of about 0.3 to about 5 mg/ml and relative amounts of hyaluronic acid to crosslinked (e.g., (2-vinylsulfonyl)ethoxy)hyaluronic acid/PEG-dithiol) hydrogel particles in the composition fall within a range from about 10:1, or about 5:1 or about 3:1 or about 1:1 which overlaps the claimed range of about 10:1 to about 1:10 (see entire document including e.g., claims 1, 5 and 8, [0084], [0113], [0132], and Example 8 of prior art). MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). The said reaction reads on the claimed condition enabling formation of the hydrogel (instant claims 1 & 17-20 (in part); and claims 2, 3, 9, 12-16 and 21).
However, Gravett does not expressly teach intrinsic viscosity of hydrogel forming polymer (e.g., hyaluronic acid) of instant claims 1, 17, 20 and 22. The deficiency is cured by Yoneto and Kakinoki.
Yoneto teaches an oral mucosa application material comprising a polymer and the polymer contains 50% or more hyaluronic acid (HA) which can be modified ([0033]-[0034]) wherein the HA can be, and wherein HA has an intrinsic viscosity 3 dL/g or higher as measured viscometer (e.g., [0014]-[0015] and [0031]) which is identical to the claimed range or overlaps the instant range and HA has a molecular weight of 1x105 or higher to provide improved retention to oral mucosal surface ([0030]).
Kakinoki discloses hyaluronic acid (HA) is useful for pharmaceuticals (e.g., joint function improving agents and ophthalmic surgery adjuvants), cosmetics, foods, and the like (page 17, first para of translation), and for example HA is also useful to improve oral mucosal pain, etc. (page 16 of translation) and HA with Mw of 300k to 1,200K has intrinsic viscosity has 7-20dl/g (page 14 of translation) which overlaps the instant range of at least 3 dL/g.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
1. The difference between the instant application and Gravett is that Gravett does not expressly teach intrinsic viscosity of hydrogel forming polymer of instant claims 1, 17, 20 and 22. The deficiency is cured by Yoneto and Kakinoki.
2. Gravett in view of Yoneto and Kakinoki do not expressly teach the claimed properties of viscosity/ storage and loss modulus/viscosity/yield strain of instant claims 1 and 18-19.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a relevant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medical, pharmacy, physiology and chemistry— without being told to do so.
Indeed, MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). This is because “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.” (MPEP 2141.03(1)) and an artisan must be presumed to know something about the art apart from what the references disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. (MPEP 2141.03 (I)). “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07). In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(11)).
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of the skilled in the art to further define hydrogel forming polymer such as modified hyaluronic acid (HA) of Gravett with intrinsic viscosity as taught by Yoneto/Kakinoki or to select certain intrinsic viscosity of Yoneto/Kakinoki.
One of the skilled in the art would have been motivated to do so because it is well known that HA or its derivatives is useful in pharmaceuticals as taught by Gravett, and in particular, Yoneto requires overlapping intrinsic viscosity of HA to provide improved retention to oral mucosal surface and Kakinoki also teaches overlapping intrinsic viscosity of HA in order to improve joint function and/or retain it onto mucosal surface to reduce oral pain.
Since Gravett in view of Yoneto/Kakinoki would achieve the claimed invention, instantly claimed hydrogel and its mechanical properties would be implicit in the absence of evidence to the contrary because the features of properties of claims 1, 17 and 18-19 are a natural result of the combination of elements. In this regard, please see Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). See also In Sandoz Inc. v. EKR Therapeutics, LLC, IPR2015-00008, slip. op. at 6 (Apr. 24, 2015), the Board found that "Petitioner's inherency argument also fails," and cited Par for the proposition that "[(Inherency may supply a missing claim limitation in an obviousness analysis" only if "the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. 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, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that the parameter of about 0.3% to about 4% or from about 0.5% to about 2% of Gravett [0132] is the unmodified hyaluronic acid and is not the same as nor is it like what is presented in claim 1 and claim 1 recites a hydrogel forming polymer with modification; and the applied references in combination do not teach that the intrinsic viscosity and concentration can help a hydrogel-forming polymer to be suitable for being spread across the surface and self-healing in view of instant Examples 3.2-3.3 using single hydrogel forming polymers.
The Examiner responds that instant claim 1 also recites “the hydrogel forming polymer is selected from unmodified “hyaluronic acid” (see the last line of claim 1) and in that context, Gravett discloses the concentration of about 0.3% (=3 mg/mL) or about 0.05 to 5% (=0.5mg/ml to 50mg/ml) of HA solution or about 0.05% to 5% (=0.5mg/ml to 50mg/ml) of final HA in the hydrogel (see [0132] and [0134] of Gravett) which is within or overlaps the claimed HA range of about 0.3 mg/ml to 5 mg/ml. MPEP 2144.05 as noted above; as supported by the instant publication ([0078]), the claimed term CT refers to the total concentration of a polymer or polymers in a composition wherein the composition may comprise hydrogel forming polymers that have already formed the hydrogel; and Yoneto/Kakinoki disclose the claimed initial viscosity before adding to the composition to enhance properties of joint function and/or oral retention, and that is, it is well known that HA is useful in pharmaceuticals, e.g., for improving joint function and/or reducing oral pain as taught by the applied art; the applicant did not provide a fair comparison between the claimed invention and the closest art; and as to the alleged unexpected results of mechanical properties based on instant Examples 3.2 and 3.3, it is noted that data (Table 2) of instant Examples is not commensurate with scope of instant claim 1 because instant claim 1 does not require at least two specific modified polymers (with or without crosslinkers) while Samples A1-A4, B1-B2 and C1 require two HA forming polymers HA-SH/HA-VA type hydrogel (see [0247]-[0248] of instant publication); and additionally, since the applied art in combination provides the claimed hydrogel composition, the claimed mechanical properties would be expected. Thus, applicant’s arguments are not persuasive.
Suggestion for considering a possible allowability
Resolve the objection and 112(b) rejection.
Incorporate of instant claim 9 into claim 1
Conclusion
The instant case is not in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613