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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 07/20/2026 is acknowledged. Additionally, Applicant’s election of the silica column as the species of shear stress application is also acknowledged. Accordingly, claims 7-9 and 15-20 are withdrawn as being drawn to non-elected inventions or species.
Status of Claims
No preliminary amendments to the claims have been filed. Claims 7-9 and 15-20 are withdrawn as discussed above. Claims 1-6 and 10-14 are examined on the merits herein.
Priority
The instant application filed 08/13/2024, is a 371 filing of PCT/KR2023/002352, filed 02/17/2023, which claims foreign priority to KR10-2022-0023658, filed 02/23/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/13/2024, 09/22/2025, and 02/27/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
Claim 1 recites wherein “the structure has a single polymer chain”. The broadest reasonable interpretation of such a limitation is any structure that has a single polymer chain within any larger solution or structure. Therefore, even if a hyaluronic acid solution comprises multiple “chains” it still contains at least one single chain of hyaluronic acid which reads on the instantly claimed “structure” regardless of any other chains present.
Claims 5-6 define a product-by-process. It is noted that "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." However, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art. See MPEP 2113. As discussed in the instant specification, the present invention relates to the structure of polymeric hyaluronic acid whose viscosity has been reduced by applying shear stress (p. 1, para. 3). As such, the imparted structure is a reduced viscosity.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
1. Claims 1-6 and 10-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed a natural phenomenon without significantly more.
The claims are evaluated below using the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in MPEP § 2106 III.
Step 1: Are the claims to a process, machine, manufacture, or composition of matter?
Yes. The claims are drawn towards a structure of polymeric hyaluronic acid. The claims read on a composition of matter, which is one of the four statutory categories.
Step 2A, Prong 1: Do the claims recite an abstract idea, law or nature, or natural phenomenon?
Yes. The claims recite a natural phenomenon. Claim 1 recites a structure of polymeric hyaluronic acid which has a single polymer chain. Hyaluronic acid is a straight-chain polymer consisting of two alternating sugars (p. 4, para. 1). It is in your eyes, your skin, your joints and it shows up in most mammalian tissue (i.e. natural phenomenon), as evidenced by Bettenhausen (2021). Hyaluronic acid is just getting started. C&EN. Vol. 99, Issue 16. (PTO-829), hereinafter Bettenhausen. Given the broadness of claim 1 and the fact that hyaluronic acid has a straight-chain polymer structure, any form of polymeric hyaluronic acid will comprise at least one single polymer chain which reads on the structure of claim 1.
When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claims on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception. See MPEP 2106.04(c)(II). In the instant case, single polymer chains of hyaluronic acid are found in nature as discussed above, and the claims do not define the hyaluronic acid structure in such a way that makes it markedly different from that found from nature. Thus, the structure of hyaluronic acid is a product of nature exception.
Step 2A, Prong 2: Do the claims recite additional elements that integrate the judicial exception into a practical application?
No. The judicial exception is not integrated into a practical application because there is no indication in the instant specification that the claimed structure of polymeric hyaluronic acid that has a single polymer chain is different or more beneficial than single polymer chains of hyaluronic acid found in nature.
Step 2B: Do the claims recite additional elements that amount to significantly more than the judicial exception?
No. The structure and use of polymeric hyaluronic acid is well-understood, routine, and conventional, as evidenced Bettenhausen.
As such, the claims do not amount to significantly more than the exception itself, the claim is not patent-eligible
Claim Rejections - 35 USC § 112(b)
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.
1. Claims 1-6 and 10-14 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 “a structure of polymeric hyaluronic acid, which is a structure derived from polymeric hyaluronic acid”. Such a limitation is confusing and does not differentiate between the polymeric hyaluronic acid which is claimed versus the polymeric hyaluronic acid which it is derived from, since both read on “structures of polymeric hyaluronic acid”. It is further unclear in the subsequent dependent claims 2-6 and 10-14, which hyaluronic acid is being referred to.
Claim 10 recites wherein a solution containing the structure has a specific molecular weight and concentration. It is unclear if the molecular weight and concentration refers to the solution or the hyaluronic acid structure. Furthermore, the claim does not define what the 0.1 to 2.0% concentration is based on.
Claims 11-14 recites the limitation "the solution". There is no recitation of a solution in parent claim 1, meaning there is insufficient antecedent basis for this limitation in the claims.
Claim 11 recites “wherein when the structure and hyaluronic acid […] have the same molecular weight and concentration, a/b, which is the ratio of the viscosity (a) of the solution containing the structure and the viscosity (b) of the solution containing hyaluronic acid […], is 0.10 to 0.99”. Such a limitation is confusing and it is unclear if the “structure” and the “hyaluronic acid” are both present in a solution or if the claim is attempting to define a property obtained by comparing two separate solutions.
Claim 11 defines a ratio of a/b as “0.10 to 0.99”. Since the word “to” may also mean “:” in a ratio it is unclear if the ratio is 0.10:1 to 0.99:1 or 0.10:0.99. For the sake of compact prosecution the limitation will be interpreted as the former.
Claim 12 recites the limitation "the hydrophilic glass". There is no recitation of a hydrophilic glass in parent claim 1, meaning there is insufficient antecedent basis for this limitation in the claims.
Claim 13 recites the limitation "the hydrophobic glass". There is no recitation of a hydrophobic glass in parent claim 1, meaning there is insufficient antecedent basis for this limitation in the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-6, 10, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park, J. et al. (KR 20210015377 A, 02/10/2021, Espacenet translation used, PTO-892), hereinafter Park.
Park discloses a method for manufacturing low-viscosity hyaluronic acid (abstract).
Regarding claim 1: The method of Park results in a low-viscosity hyaluronic acid (HA) (abstract; [0027]; Ex. 1), which reads on the instantly claimed structure of polymeric hyaluronic acid. The low-viscosity HA is generated from first preparing a hyaluronic acid or salt thereof and adding it to a solvent to form a solution, followed by treating the solution with a photocatalyst-UV ray (UVTP) ([0027]; Ex. 1), which reads on being derived from polymeric hyaluronic acid. Hyaluronic acid is a polymer compound in which N-acetylglucosamine and glucuronic acid are alternately bonded in a chain shape ([0002]), therefore reading on a structure that has a single polymer chain.
Regarding claim 4: The molecular weight of the starting HA solution is 7.8579 x 105 g/mol, while the resulting low-viscosity HA after 30 and 60 minutes of UVTP treatment is 6.7448 x 105 and 2.4603 x 105g/mol, respectively ([0066]-[0070]; Table 4). Each of these molecular weights fall within the instantly claimed range (i.e., 5 x 104 to 5 x 106 g/mol).
Regarding claim 5: The photocatalyst-ultraviolet treatment step comprises irradiating ultraviolet rays while circulating hyaluronic acid in a tube coated with the photocatalyst ([0015]; Ex. 1). The circulation of HA reads on applying shear stress to a solution containing hyaluronic acid.
Regarding claim 6: As discussed above, a product-by-process claim is only defined by the product itself and the structure which is imparted by the claimed process. The instant specification teaches that the application of shear stress achieves a reduced viscosity hyaluronic acid (p. 1, para. 2). As such, the imparted structural feature is an HA solution of reduced viscosity. Park explicitly teaches a hyaluronic acid with a lower viscosity ([0001]; claim 2). Additionally, Park explicitly teaches HA solutions with the same molecular weight, concentration, and viscosity of claim 10, see the rejection below. As such, the product provided by the instantly claimed process is taught and anticipated by the product of Park, despite the fact that it is made with a different process.
Regarding claim 10: Example 1 teaches applying photocatalyst-ultraviolet (UVTP) to a 1% HA solution ([0040]-[0041]), which falls within the instantly claimed concentration (i.e., 0.1 to 2%). The resulting viscosity after 30 min and 60 min of UVTP treatment is 690 cP and 182.4 cP, respectively ([0043]-[0045]; Table 1), both of which fall within the instantly claimed range (i.e., 10 to 700 cP). The resulting molecular weight after 30 min and 60 min of UVTP treatment is 6.7448 x 105 and 2.4603 x 105g/mol, respectively ([0066]-[0070]; Table 4), both of which fall within the instantly claimed range (i.e., 5 x 104 to 5 x 106 g/mol).
Regarding claims 12-14: The low-viscosity hyaluronic acid of Park is identical to the structure defined in instant claims 1 and 10. Where the claimed and prior art products are identical or substantially identical in structure or composition a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112.01 I. “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP § 2112.01 II. Therefore, it is expected that the hyaluronic acid of the prior art possesses the properties as claimed (i.e., contact angle against hydrophilic and hydrophobic glass as well as intrinsic viscosity) since the claimed and prior art products are identical or substantially identical in structure and composition. Since the Office does not have a laboratory to test the reference HA solution, it is applicant’s burden to show that the reference HA solution does not possess the properties as claimed in instant claims 12-14. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
Claims 1-2, 4-6, and 10-14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Liu, M. et al. (US 8,283,463 B2, 10/09/2012, IDS dated 09/22/2025), hereinafter Liu.
Liu discloses a process for sterilizing a solution comprising hyaluronic acid (abstract).
Regarding claim 1: The process comprises preparing an aqueous, high salt, hyaluronic acid solution followed by heat treatment and filtering to provide a sterilized high salt, hyaluronic acid solution (abstract; Example 1; claim 1). The sterilized, high salt, HA therefore reads on the instantly claimed structure of polymeric hyaluronic acid, which is derived from the polymeric hyaluronic acid in the initial solution. Hyaluronic acid is a linear polysaccharide (long-chain biological polymer) formed by repeating disaccharide units consisting of D-glucuronic acid and N-acetyl-D-glucosamine (col. 3, lines 54-57), which reads on a structure that has a single polymer chain.
Regarding claim 2: The aqueous solution has an ionic strength equivalent to an aqueous concentration of sodium chloride from 3% to 30% by weight (abstract). FIG. 2 shows a schematic representation of a random coiled, hyaluronic acid polymer in aqueous solution with different ionic strength (ionic salt concentrations) (col. 3, lines 36-38). The increase in ionic strength of the aqueous hyaluronic acid solution may be referred to as a "salt shrink wrapping" of the polymer. The "salt shrink wrapping" of the hyaluronic acid is best described by the schematic representation of a random coiled, hyaluronic acid in aqueous solution shown in FIG. 2 (col. 5, lines 26-34):
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Therefore, the high salt solution of hyaluronic acid causes single polymer chains to form an ionic aggregate.
Regarding claim 4: The aqueous solution comprises hyaluronic acid with a weight average molecular weight from 0.6 MDa to 3.6 MDa (abstract; claim 1), with Example 1 using HA with an average molecular weight of about 1.8 MDa (col. 7, lines 31-35). Each of these molecular weights fall within the instantly claimed range (i.e., 5 x 104 to 5 x 106 g/mol).
Regarding claim 5: The process comprises a step of filtering the heated, high salt, hyaluronic acid solution through a sterilization filter medium (abstract; col. 7, lines 63-66; claim 1), which reads on applying shear stress to a solution containing hyaluronic acid. Liu teaches that methods of filter sterilizing a high molecular weight hyaluronic acid at a relatively low hyaluronic acid concentration can reduce the viscosity of the solution (col. 2, lines 8-11), which also reads on the structure imparted by the claimed process, as discussed in the claim interpretation section above.
Regarding claim 6: The recitation of “passing a solution […] through a column filled with silica” defines a product-by-process, as discussed above. The instant specification teaches that the application of shear stress achieves a reduced viscosity hyaluronic acid (p. 1, para. 2). As such, the imparted structural feature is an HA solution of reduced viscosity. Liu teaches a filter sterilization method (abstract) and that filter sterilizing a high molecular weight hyaluronic acid at a relatively low hyaluronic acid concentration can reduce the viscosity of the solution (col. 2, lines 8-11), which reads on the imparted structural feature regardless of the type of shear stress applied. Additionally, Liu explicitly teaches HA solutions with the same molecular weight, concentration, and viscosity of claim 10, see the rejection below. As such, the product provided by the instantly claimed process is taught and anticipated by the product of Liu, despite the fact that it is made with a different process. Lastly, the instant specification teaches that other means of applying shear stress include passing an HA solution through filter paper with a pore size of 0.1 to 5.0 microns (p. 4, para. 3-4; p. 10, para. 4). Liu teaches a sterile filtration process using a 0.22 micron pore size PES or PVDF filter cartridge (col. 7, lines 63-65; col. 4, lines 39-45), which one of ordinary skill in the art would recognize as a process of applying shear stress which would impart the same structure imparted by the silica column as claimed.
Regarding claim 10: Solution A of Example 1 is prepared from a 0.5 wt. % hyaluronic acid (HA) aqueous solution (col. 7, lines 31-33), which falls within the instantly claimed range (i.e., 0.1 to 2%). The HA had a reported weight average molecular weight of about 1.8 MDa (col 7, lines 34-36), which falls within the instantly claimed range (i.e., 5 x 104 to 5 x 106 g/mol), and a cone/plate viscosity of 304 cP at 1 rpm, 111 cP at 17 rpm (col 7, lines 38-39), both of which fall within the instantly claimed range (i.e., 10 to 700 cP).
Regarding claim 11: Example 7A teaches a high salt hyaluronic acid solution prepared containing 0.26 wt. % HA and 13 wt. % NaCl and dissolved under heat. The solution was cooled to about 40oC in about 10 mins and maintained at about 40oC. Samples were taken at 0 hr, 1 hr, 2 hr, 3 hr, 4 hr and 18 hr to collect molecular weight and viscosity data (col. 9, lines 22-37). At time 0 and time 2 the HA solutions have the same molecular weight and a viscosity of 22.6 and 21.9, respectively (Table 3). The concentration of the HA must necessarily stay the same since none is added or removed throughout the heating process. The time 0 sample may read on a solution containing hyaluronic acid (a), which is a precursor of the structure, and the time 2 sample may read on a solution containing the structure (b). The ratio of a/b is therefore 0.96 (i.e., 21.9/22.6) which falls within the instantly claimed range (i.e., 0.10 to 0.99), when the molecular weight and concentration are the same.
Regarding claims 12-14: The sterilized, high salt, hyaluronic acid solution of Liu is identical to the structure defined in instant claim 1. Furthermore, the HA solution of Liu forms ionic aggregates, uses hyaluronic acid within the instantly claimed molecular weight range and concentration, and has the instantly claimed viscosity in cP. Where the claimed and prior art products are identical or substantially identical in structure or composition a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112.01 I. “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP § 2112.01 II. Therefore, it is expected that the hyaluronic acid of the prior art possesses the properties as claimed (i.e., contact angle against hydrophilic and hydrophobic glass as well as intrinsic viscosity) since the claimed and prior art products are identical or substantially identical in structure and composition. Since the Office does not have a laboratory to test the reference HA solution, it is applicant’s burden to show that the reference HA solution does not possess the properties as claimed in instant claims 12-14. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
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.
1. Claims 1-6 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Liu, M. et al. (US 8,283,463 B2, 10/09/2012, IDS dated 09/22/2025), hereinafter Liu.
The teachings of Liu are discussed above, as are the rejections of claims 1-2, 4-6, and 10-14.
As discussed above, Liu discloses a process for sterilizing a solution comprising hyaluronic acid, specifically by filtering an aqueous solution through a sterilization filter medium (abstract). Liu also provides processing conditions that improve the filtration efficiency of aqueous hyaluronic acid solutions. In particular, the described processing conditions make possible the sterilization of relatively large scale, production batches of aqueous hyaluronic acid solutions (col. 4, lines 35-39). It is taught that high molecular weight hyaluronic acid can be filtered more easily by reducing the viscosity of the solution (col. 2, lines 16-18) and an increase in the ionic strength of a [hyaluronic acid] solution results in a decrease in viscosity (col. 2, lines 38-40). As such, one of the processing conditions taught by Liu involves the ionic strength of the aqueous hyaluronic acid solution. The ionic strength values are stated and described as an equivalent to a stated aqueous concentration of sodium chloride. The increase in ionic strength of the aqueous hyaluronic acid solutions results in a "salt shrink wrapping" of the polymer. The "salt shrink wrapping" of the hyaluronic acid is best described by the schematic representation of a random coiled, hyaluronic acid in aqueous solution shown in FIG. 2 (col. 5, lines 26-41):
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Such a coiled structure reads on an ionic aggregate and appears to form a spherical structure. Accordingly, a sufficient amount of one or more salt compounds are combined with the hyaluronic acid to provide an aqueous high salt, hyaluronic acid solution having an ionic strength equivalent to an aqueous concentration of sodium chloride of from 3 wt. % to 30 wt. % (col. 5, lines 26-41). In summary, Liu teaches generating high ionic strength HA solutions to cause salt shrinkage of the polymer which in turn lowers the solution viscosity and enables more efficient filtering.
The teachings of Liu differ from that of the instant invention in that Liu does not explicitly teach the diameter of the ionic aggregates as recited in claim 3
However, it would have been prima facie obvious to one of ordinary skill in the art to provide a solution having ionic aggregates with a diameter within the instantly claimed range (i.e., 1-20 nm) since diameter (i.e., shrinking) is an optimizable parameter which is directly related to the ionic strength and viscosity of the solution. Liu teaches that as ionic strength increases, shrinking (i.e., diameter) of the polymer also decreases along with viscosity. Such an effect is desirable as it allows the solution to pass through a filter more efficiently. It is well within the abilities of an ordinary artisan to optimize the degree of polymer shrinking (i.e., aggregate diameter) in the composition depending on the desired viscosity and filter efficiency of the solution. As such, one of ordinary skill in the art would have arrived at the instantly claimed diameter of claim 3 through no more than routine experimentation. "[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). Moreover, the optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). One of ordinary skill in the art would have had a reasonable expectation of success in performing such an optimization since Liu teaches that the shrinkage/diameter can be adjusted simply by adjusting the sodium chloride concentration of the solution.
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.
1. Claims 1-6 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/838,123 (reference application) as evidenced by Liu (above). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate every element of the instant independent claim.
Copending claim 1 recites a high-molecular-weight hyaluronic acid structure, which is derived from high-molecular-weight hyaluronic acid, wherein the viscosity of solution containing the structure is 1 to 60 cP. While not explicitly recited, high-molecular-weight hyaluronic acid would be recognized by one of ordinary skill in the art as polymeric hyaluronic acid. Regarding the instantly claimed single polymer chain structure, hyaluronic acid is a linear polysaccharide (long-chain biological polymer) formed by repeating disaccharide units consisting of D-glucuronic acid and N-acetyl-D-glucosamine, as evidenced by Liu (col. 3, lines 54-57). Thus, any hyaluronic acid reads on a structure that has a single polymer chain.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 9-5 (Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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