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 .
Status of the Application
Claims 1-16 and 18-20 are pending, of which Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-16 and 18 are under current examination.
Amendment necessitated new claim rejection as set forth below.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Iwasaki (US 20130189231 A1).
Determining the scope and contents of the prior art
Iwasaki teaches a sterile, ready to use alginate aqueous composition packed in dispenser device, a pre-filled syringe (vial), pressurized (expected to be packed by replacing air with N2 for pharmaceutical use and to avoid contamination or degradation under air) syringe (air tight container), filler (vial) for filling the syringe, as a pharmaceutical (thus ready-to-use) in a dose of 1-5ml, preferably 2-3ml, for human use (expected to be sealed under N2 or air tight container as the drug is for human consumption to avoid contamination) consisting of 1-5%, preferably 1.5-3%, more preferably 2-2.5%, with working example of 2% w/v (=2% mass in liquid; considering density of water as 1g/cm3) of sodium alginate of MW with examples, such as 320K, 480K, 400K (with example), 500K (determined by gel filtration) or examples of 185K, 149K, 128K (as determined by SEC-MALLS, same as GPC-MALS method as provided in the instant specification:
PNG
media_image1.png
276
556
media_image1.png
Greyscale
) (paragraphs 0077, 0250-0270) or with endotoxin level less than 100EU/g, preferably 50EU/g or less, more particularly less than 30EU/g (paragraph 0090)-thus reads limitation of low endotoxin of the instant claims) in physiological saline (0.9% by mass NaCl in water) with viscosity of examples about 5000mPa.S (entire article, especially abstract; paragraph 0077-0101, 0122-0133, 0139-0155, 0242, 0250-0270 and claims).
With regard to limitations of the instant claims “viscosity, viscosity rate, and storage stability”–Since composition is inseparable from its physical and chemical properties, composition of the cited prior art having same components is expected to possess same properties as in the instant claims.
Ascertaining the differences between the prior art and the claims at issue
Iwasaki teaches applicant’s sterile, ready to use alginate aqueous composition comprising sodium alginate of MW with examples, such as 320K, 480K, 400K (with example), 500K (determined by gel filtration) or examples of 185K, 149K, 128K (as determined by SEC-MALLS, same as GPC-MALS method as provided in the instant specification) and thus different with respect to MW 250K and 150K. The cited prior art fails to teach storing in a vial of a particular size and under N2 gas.
Resolving the level of ordinary skill in the pertinent art
With regard to limitations of the instant claims of storing the composition in a vial of particular size - Iwasaki teaches a sterile, ready to use alginate aqueous composition packed in dispenser device, a pre-filled syringe (vial), pressurized (expected to be packed by replacing air with N2 for pharmaceutical use and to avoid contamination or degradation under air) syringe (air tight container), filler (vial) for filling the syringe, as a pharmaceutical (thus ready-to-use) in a dose of 1-5ml, preferably 2-3ml. Thus, based on the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art to store and ship composition in an appropriate packing or container of size depending on the amount of the composition for one use, such as dose of 5ml or 2-3ml or multiple uses. The cited prior art teaches dose of 5ml or 2-3 ml. Thus, a person of ordinary skill in the art would have been motivated to either have vial with a single dose such as 2-3ml as suggested by the cited prior art or for multiple uses, such as 10 uses of 20ml vial etc. Further, a person of ordinary skill in the art would have been motivated to store and ship any pharmaceutical composition in appropriate packing material such as vials of appropriate size etc. to prevent waste of money and product.
With regard to limitations of the instant claim of storing the composition in a vial under N2 gas- - Since Iwasaki teaches a sterile, ready to use alginate aqueous composition packed in dispenser device, a pre-filled syringe (vial), pressurized syringe (air tight container), filler (vial) for filling the syringe, as a pharmaceutical for human use, it would have been prima facie obvious to a person of ordinary skill in the art to store composition in an appropriate container under gas such as N2 or argon to prevent degradation of the composition and to increase shelf life and it is a routine practice in the art. A person of ordinary skill in the art would have been motivated to store pharmaceutical composition under gas such as N2 or argon to prevent degradation of the composition and to increase shelf life. Importantly, since Iwasaki teaches a sterile, ready to use alginate aqueous composition packed in dispenser device, a pre-filled syringe (vial), pressurized syringe (air tight container), to maintain pressure, sterile environment, the composition is expected to be packed by replacing air with N2 for pharmaceutical use and to avoid contamination or degradation under air.
With regard to limitations of the instant claims of MW 250K and 150K - Iwasaki teaches applicant’s sterile, ready to use alginate aqueous composition comprising sodium with examples, such 320K, 480K, 400K, 500K (determined by gel filtration) or examples of 185K (close to 250K), 149K (touching 150K) , 128K (as determined by SEC-MALLS, same as GPC-MALS method as provided in the instant specification). Since the cited prior art teaches that the pharmaceutical composition may use sodium alginate of MW (10K-100K) (encompass MW of the instant claims) and provide specific examples of 185K (close to 250K), 149K (touching 150K), 128K (as determined by SEC-MALLS, same as GPC-MALS method as provided in the instant specification), it would have been prima facie obvious to a person of ordinary skill in the art that that the pharmaceutical composition may be made using sodium alginate of MW close to 185K (close to 250K), 149K (touching 150K), 128K with a reasonable expectation of success. Further, a person of ordinary skill in the art would have been motivated to use sodium alginate close to 185K (close to 250K), 149K (touching 150K), because the cited prior art teaches that the composition with sodium alginate close to 185K (close to 250K), 149K (touching 150K) is superior than lower MW.
PNG
media_image2.png
222
556
media_image2.png
Greyscale
When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation. In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with "sufficient specificity to constitute an anticipation under the statute." What constitutes a "sufficient specificity" is fact dependent. If the claims are directed to a narrow range, and the reference teaches a broader range, other facts of the case, must be considered when determining whether the narrow range is disclosed with "sufficient specificity" to constitute an anticipation of the claims. Compare ClearValue Inc. v. Pearl River Polymers Inc., 668 F.3d 1340, 101 USPQ2d 1773 (Fed. Cir. 2012) with Atofina v. Great Lakes Chem. Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423 (Fed. Cir. 2006).
In ClearValue, the claim at issue was directed to a process of clarifying water with alkalinity below 50 ppm, whereas the prior art taught that the same process works for systems with alkalinity of 150 ppm or less. In holding the claim anticipated, the court observed that "there is no allegation of criticality or any evidence demonstrating any difference across the range." Id. at 1345, 101 USPQ2d at 1777. In Atofina, the court held that a reference temperature range of 100-500 degrees C did not describe the claimed range of 330-450 degrees C with sufficient specificity to be anticipatory, even though there was a slight overlap between the reference’s preferred range (150-350 degrees C) and the claimed range. "[T]he disclosure of a range is no more a disclosure of the end points of the range than it is each of the intermediate points." Id. at 1000, 78 USPQ2d at 1424. Patentee described claimed temperature range as "critical" to enable the process to operate effectively, and showed that one of ordinary skill would have expected the synthesis process to operate differently outside the claimed range.
In 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Iwasaki teaches applicant’s sterile, ready to use alginate aqueous composition comprising sodium alginate.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, it would have been prima facie obvious to a person of ordinary skill in the art to store pharmaceutical composition in an appropriate container and size depending on the amount of the composition and for one use or multiple use and can be made by the cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed composition with a reasonable expectation of success.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16 and 18 in the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 7, 13 and 14 of U.S. Patent No. 9216201 B2; claims 1-10 of U.S. Patent No. 11969437 B2; and claims 1-21 of U.S. Patent No. 10966929 B2, since the claims, if allowed, would improperly extend the “right to exclude" already granted in the patent.
Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of instant application and claims 1, 7, 13 and 14 of U.S. Patent No. 9216201 B2; claims 1-10 of U.S. Patent No. 11969437 B2; and claims 1-21 of U.S. Patent No. 10966929 B2, are drawn to a composition comprising same components as in the instant claims or a process of using composition comprising same components as in the instant claims (i.e., discloses composition), with a difference in wording or scope.
The difference of wording, such as molecular weight by gel filtration vs GPC-MALS with respect to U.S. patent 9216201 B2 because U.S. patent 9216201 B2 provides MW of 500,000 or more by gel filtration. Specification of U.S. patent 9216201 B2 provides examples of compositions with 500,000 or more by gel filtration measured by another method SEC-MALLS (which is same as GPC-MALS) and examples encompassed by the range as 185K, 149K etc. (encompassed by the instant claims).
The difference of scope of claims of the instant application and claims 1-10 of U.S. Patent No. 11969437 B2; and claims 1-21 of U.S. Patent No. 10966929 B2, however, does not constitute a patentable distinction, because the claims in the present invention encompass scope of claims 1-10 of U.S. Patent No. 11969437 B2; and claims 1-21 of U.S. Patent No. 10966929 B2. For the foregoing reasons, the instantly claimed process is made obvious.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See also MPEP § 804.
Response to Arguments
Applicant’s amendment and remarks, filed on 07/14/2025, have been fully considered but not found persuasive.
Applicant argue and made general comments with different case laws that it would not be obvious without teaching or guidance in the prior art. Applicant argue that Iwasaki does not explicitly teach properties of composition of the instant claims. Applicant argue that the composition of the instant claims is obtained by first preparing a low-concentration aq. Solution etc., steps giving the composition features, such as storage stability, viscosity etc.
PNG
media_image3.png
790
993
media_image3.png
Greyscale
PNG
media_image4.png
910
720
media_image4.png
Greyscale
This is not found persuasive and the instant claims are obvious over the cited prior art. This is because (1) applicant is arguing over limitations of process steps not recited in the instant claims; (2) Iwasaki teaches a sterile, ready to use alginate aqueous composition packed in dispenser device, a pre-filled syringe (vial), pressurized (expected to be packed by replacing air with N2 for pharmaceutical use and to avoid contamination or degradation under air) syringe (air tight container), filler (vial) for filling the syringe, as a pharmaceutical (thus ready-to-use) in a dose of 1-5ml, preferably 2-3ml, for human use (expected to be sealed under N2 or air tight container as the drug is for human consumption to avoid contamination) consisting of 1-5%, preferably 1.5-3%, more preferably 2-2.5%, with working example of 2% w/v (=2% mass in liquid; considering density of water as 1g/cm3) of sodium alginate of MW with examples, such as 320K, 480K, 400K (with example), 500K (determined by gel filtration) or examples of 185K, 149K, 128K (as determined by SEC-MALLS, same as GPC-MALS method as provided in the instant specification:
PNG
media_image1.png
276
556
media_image1.png
Greyscale
) (paragraphs 0077, 0250-0270) or with endotoxin level less than 100EU/g, preferably 50EU/g or less, more particularly less than 30EU/g (paragraph 0090)-thus reads limitation of low endotoxin of the instant claims) in physiological saline (0.9% by mass NaCl in water) with viscosity of examples about 5000mPa.S (entire article, especially abstract; paragraph 0077-0101, 0122-0133, 0139-0155, 0242, 0250-0270 and claims). With regard to limitations of the instant claims “viscosity, viscosity rate, and storage stability”–Since composition is inseparable from its physical and chemical properties, composition of the cited prior art having same components is expected to possess same properties as in the instant claims; (3) The cited prior art teaches every element of the instant claims including MW range and several examples within the range and ranges close to dependent claims.
Applicant argued over ODP rejection only over U.S. Patent No. 9216201 that the instant claims require viscosity measured at 20C:
PNG
media_image5.png
435
650
media_image5.png
Greyscale
This is not found persuasive and the instant claims stand rejected under ODP. This is because U.S. Patent No. 9216201 teaches same composition as in the instant claims and properties, such as viscosity” is expected to be exhibited by the U.S. Patent No. 9216201, whether or not measured. This is because a composition is inseparable from its physical and chemical properties.
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.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
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, Milligan Adam can be reached on 571-2707674. 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.
/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623