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 .
DETAILED ACTION
The Applicant’s reply filed on 5/8/26 is acknowledged. Claims 4, 9, 15, 21, 24, 26, 32, 33, 35-37, 39, 41, 42, 44-46, 48 and 78-82 are pending. Claims 79-82 are new. Claims 1 and 9 have been amended.
Claims 41, 42, 44-46, 48 and 78 have been withdrawn. New claim 82 is withdrawn as being directed to a process for obtaining a biopolymer composition, which would have been included in unelected Group III had it been presented earlier.
Applicant’s election of the species of:
a. Chitosan for the species of biopolymer, is maintained.
b. Consisting essentially of biopolymer and water for the species of biopolymer
composition, is modified in view of the amendment to claim 4. Claims 41, 42, and 78 remain withdrawn as they are not required for the compositions of Claim 4 and their presence was not elected.
c. Ball milling for the species of process for obtaining the biopolymer, is withdrawn as it is directed to the method and not to the composition.
Claims 4, 9, 15, 21, 24, 26, 32, 33, 35-37, 39, 79, 81 and 82 are under consideration to the extent that the biopolymer composition comprises the elected species.
Objections Withdrawn
The objection to claim 9 is withdrawn in view of the amended claim.
Rejections Withdrawn
The rejection of Claims 4, 6, 9, 33, and 35-37 under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN 103316641) is withdrawn in view of the amended claim(s).
The rejection of Claims 4, 6, 9, 15, 21, 24, 26, 32, 33, and 35-37 under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 103316641) in view of Davidson et al. (US 6,638,918; cited in IDS) is withdrawn in view of the amended claim(s).
Rejections Maintained and New Grounds of Rejections
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 5/8/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 81 and 82 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 81, there does not appear to be support for the claimed pH range, throughout the Specification, or in the paragraphs and Example pointed to by Applicant. The disclosure does not disclose a pH of 6 to 8 for a composition selected from the group consisting of a paste, an ointment, a cream, a lotion, a gel and a milk.
Regarding Claim 82, there does not appear to be support for the claimed concentration of biopolymer, throughout the Specification, or in the paragraphs and Example pointed to by Applicant. The disclosure does not teach appear to disclose a concentration biopolymer in a composition selected from the group consisting of a paste, an ointment, a cream, a lotion, a gel and a milk.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 and 39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 33 recites that “said biopolymer composition consists essentially of said biopolymer and water”. However, Claim 1 has been amended to recite that the suspension is selected from the group consisting of a paste, an ointment, a cream, a lotion, a gel and a milk, which would require additional ingredients. Claim 33 does not include all the limitations of the claim upon which it depends because a composition consisting essentially of said biopolymer and water would exclude paste, an ointment, a cream, a lotion, a gel and a milk.
Claim 1 has been amended to include the suspension is selected from the group consisting of a paste, an ointment, a cream, a lotion, a gel and a milk. Claim 39 also recites the same Markush group of suspensions and does not further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 4, 9, 35-37, 39 and 79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davidson et al. (US 6,638,918; cited in IDS).
Davidson et al. teach compositions comprising chitosan in the form of a network of nano-sized fibers (e.g. abstract). The compositions have improved solubility and activity, and are useful in hair care, skin care, odor control, wound care, blood management, sanitary compositions, oral care, film formation, hard surface treatment, fabric treatment, release of hydrophobic or hydrophilic materials, plant care, water purification and drug delivery (e.g. abstract; column 1, lines 5-10). Davidson et al. teach that the composition may be in the form of a suspension, dispersion or paste (e.g. column 5, lines 55-62), and further in the form of a toothpaste, cream, gel, or milk (e.g. column 5, lines 55-62; column 6, lines 48-62; column 17, lines 39-43; Claims 6 and 7). Davidson et al. further teach the inclusion of water (e.g. column 16, lines 43-52; column 18, line 47- column 19, line 57; column 23, lines 62-end; Examples).
Regarding Claims 4, 9, and 39, Davidson et al. exemplify a gel comprising chitosan and water (e.g. Example 14 in column 31).
Regarding Claim 35, Davidson’s Example 14 is free from added acid.
Regarding Claims 36, 37 and 79, it is noted that the limitation “is obtained by a process…” is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In the instant case, the product of claims 36, 37 and 79 is anticipated by Davidson’s Example 14. “[E]ven 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
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.
Claims 4, 9, 15, 21, 24, 26, 32, 35-37, 39, 79, 81 and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al. (US 6,638,918; cited in IDS).
Regarding Claims 4, 9, 35-37, 39 and 79, the teachings of Davidson et al. are described supra.
Regarding Claim 15, Davidson et al. teach that the nano-size fibers have an average length ranging from about 50 nm to about 100 nm, a width ranging from about 5 nm to about 30 nm, and a thickness ranging from about 1 nm to about 10 nm, as determined by cryogenic transmission electron microscopic imaging, which overlap with the claimed ranges. 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) (MPEP 2144.05.I).
Regarding Claims 21, 24 and 26, it is noted that the instant Specification definition of “particle” includes “fiber” (e.g. paragraphs 0009, 000102). Table 4 includes chitosan sizes of 85, 103 and 110 nm. The values disclosed by Davidson et al. overlap those claimed. 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) (MPEP 2144.05.I).
Regarding Claim 32, Davidson et al. further teach the inclusion of viscosity modifiers and thickeners (e.g. column 15, lines 40-47; column 27, lines 47-60) and that the composition may be in the form of a paste, toothpaste, cream, gel, or milk (e.g. column 5, lines 55-62; column 6, lines 48-62; column 17, lines 39-43; Claims 6 and 7). It would have been obvious to one of ordinary skill in the art at the time of filing to vary the viscosity via the addition of viscosity modifiers and thickeners to produce a suitable composition in the form of a paste, toothpaste, cream, or gel, and arrive at a viscosity of 20 mPa*s to 100,000 mPa*s though routine optimization. It is obvious to optimize within prior art conditions or through routine experimentation.
Regarding Claim 81, Davidson et al. teach that the pH is in the range of about 2-10, which overlaps with the claimed range (e.g. column 16, lines 47-51).
Regarding Claim 82, Davidson et al. teach that the chitosan is present in the composition at a concentration of 0.1-15%, which overlaps with the claimed range (e.g. column 5, lines 55-62).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 4, 9, 15, 21, 24, 26, 32, 33, 35-37, 39, 79, 81 and 82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 28-33, and 35-45 of copending Application No. 18/879,362 in view of Davidson et al. (US 6,638,918; cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims require a biopolymer composition comprising a stable homogeneous suspension of an insoluble and/or semi-soluble biopolymer in a polar solvent.
Claims 4 and 9 are met by copending Claim 1.
Claim 6 is met by copending Claim 33.
Claims 33 and 35 are met by copending Claim 32.
Claims 36 and 37 are met by copending Claim 29.
Copending ‘362 does not teach the size of the biopolymers. This is made up for by the teachings of Davidson et al.
Davidson et al. teach compositions comprising chitosan in the form of a network of nano-sized fibers (e.g. abstract). The compositions have improved solubility and activity, and are useful in hair care, skin care, odor control, wound care, blood management, sanitary compositions, oral care, film formation, hard surface treatment, fabric treatment, release of hydrophobic or hydrophilic materials, plant care, water purification and drug delivery (e.g. abstract; column 1, lines 5-10). Davidson et al. teach that the nano-size fibers have an average length ranging from about 50 nm to about 100 nm, a width ranging from about 5 nm to about 30 nm, and a thickness ranging from about 1 nm to about 10 nm, as determined by cryogenic transmission electron microscopic imaging, which overlap with the claimed ranges.
It would have been obvious to one of ordinary skill in the art at the time of filing to select the fiber/particle sizes of Davidson et al. for use with the biopolymers of ‘362. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions directed to fibers of chitosan, and one of ordinary skill would have been motivated to select the sized of Davidson et al. as their particles are taught to have improved solubility and activity.
Regarding Claim 15, the values disclosed by Davidson et al. overlap those claimed. 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) (MPEP 2144.05.I).
Regarding Claims 21, 24 and 26, it is noted that the instant Specification definition of “particle” includes “fiber” (e.g. paragraphs 0009, 000102). Table 4 includes chitosan sizes of 85, 103 and 110 nm. The values disclosed by Davidson et al. overlap those claimed. 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) (MPEP 2144.05.I).
Regarding Claim 32, as the composition of ‘362 and Davidson et al. comprises the claimed ingredients (chitosan and water) in the claimed sizes, prepared by the claimed method, then the viscosity of the resulting solution would necessarily be within the claimed ranges. “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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 9, 15, 21, 24, 26, 32, 33, 35-37, 39, 79, 81 and 82 are directed to an invention not patentably distinct from claims 1-3, 28-33, and 35-45 of commonly assigned 18/879,362. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/879,362, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 4, 9, 15, 21, 24, 26, 32, 33, 35-37, 39, 79, 81 and 82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 17-22 of copending Application No. 18/879,363 in view of Davidson et al. (US 6,638,918; cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims require a biopolymer composition comprising a stable homogeneous suspension of an insoluble and/or semi-soluble biopolymer in a polar solvent.
Claims 4 and 9 are met by copending Claims 1 and 17.
Claim 6 is met by copending Claim 8 and 22.
Claims 33 and 35 are met by copending Claim 7.
Claims 36 and 37 are met by copending Claim 17.
Copending ‘363 does not teach the size of the biopolymers. This is made up for by the teachings of Davidson et al.
Davidson et al. teach compositions comprising chitosan in the form of a network of nano-sized fibers (e.g. abstract). The compositions have improved solubility and activity, and are useful in hair care, skin care, odor control, wound care, blood management, sanitary compositions, oral care, film formation, hard surface treatment, fabric treatment, release of hydrophobic or hydrophilic materials, plant care, water purification and drug delivery (e.g. abstract; column 1, lines 5-10). Davidson et al. teach that the nano-size fibers have an average length ranging from about 50 nm to about 100 nm, a width ranging from about 5 nm to about 30 nm, and a thickness ranging from about 1 nm to about 10 nm, as determined by cryogenic transmission electron microscopic imaging, which overlap with the claimed ranges.
It would have been obvious to one of ordinary skill in the art at the time of filing to select the fiber/particle sizes of Davidson et al. for use with the biopolymers of ‘363. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions directed to fibers of chitosan, and one of ordinary skill would have been motivated to select the sized of Davidson et al. as their particles are taught to have improved solubility and activity.
Regarding Claim 15, the values disclosed by Davidson et al. overlap those claimed. 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) (MPEP 2144.05.I).
Regarding Claims 21, 24 and 26, it is noted that the instant Specification definition of “particle” includes “fiber” (e.g. paragraphs 0009, 000102). Table 4 includes chitosan sizes of 85, 103 and 110 nm. The values disclosed by Davidson et al. overlap those claimed. 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) (MPEP 2144.05.I).
Regarding Claim 32, as the composition of ‘363 and Davidson et al. comprises the claimed ingredients (chitosan and water) in the claimed sizes, prepared by the claimed method, then the viscosity of the resulting solution would necessarily be within the claimed ranges. “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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 9, 15, 21, 24, 26, 32, 33, 35-37, 39, 79, 81 and 82 are directed to an invention not patentably distinct from claims 1-11 and 17-22 of commonly assigned 18/879,363. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/879,363, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 4, 6, 9, 15, 21, 24, 26, 32, 33, and 35-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 9, and 11-15 of copending Application No. 18/878,991 in view of Davidson et al. (US 6,638,918; cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims require a biopolymer composition comprising a stable homogeneous suspension of an insoluble and/or semi-soluble biopolymer in a polar solvent.
Claims 4 and 9 are met by copending Claims 4 and 5.
Claim 6 is met by copending Claim 7.
Claims 33 and 35 are met by copending Claim 6.
Claims 36 and 37 are met by copending Claim 3.
Copending ‘991 does not teach the size of the biopolymers. This is made up for by the teachings of Davidson et al.
Davidson et al. teach compositions comprising chitosan in the form of a network of nano-sized fibers (e.g. abstract). The compositions have improved solubility and activity, and are useful in hair care, skin care, odor control, wound care, blood management, sanitary compositions, oral care, film formation, hard surface treatment, fabric treatment, release of hydrophobic or hydrophilic materials, plant care, water purification and drug delivery (e.g. abstract; column 1, lines 5-10). Davidson et al. teach that the nano-size fibers have an average length ranging from about 50 nm to about 100 nm, a width ranging from about 5 nm to about 30 nm, and a thickness ranging from about 1 nm to about 10 nm, as determined by cryogenic transmission electron microscopic imaging, which overlap with the claimed ranges.
It would have been obvious to one of ordinary skill in the art at the time of filing to select the fiber/particle sizes of Davidson et al. for use with the biopolymers of ‘991. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions directed to fibers of chitosan, and one of ordinary skill would have been motivated to select the sized of Davidson et al. as their particles are taught to have improved solubility and activity.
Regarding Claim 15, the values disclosed by Davidson et al. overlap those claimed. 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) (MPEP 2144.05.I).
Regarding Claims 21, 24 and 26, it is noted that the instant Specification definition of “particle” includes “fiber” (e.g. paragraphs 0009, 000102). Table 4 includes chitosan sizes of 85, 103 and 110 nm. The values disclosed by Davidson et al. overlap those claimed. 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) (MPEP 2144.05.I).
Regarding Claim 32, as the composition of ‘991 and Davidson et al. comprises the claimed ingredients (chitosan and water) in the claimed sizes, prepared by the claimed method, then the viscosity of the resulting solution would necessarily be within the claimed ranges. “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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 9, 15, 21, 24, 26, 32, 33, 35-37, 39, 79, 81 and 82 are directed to an invention not patentably distinct from claims 1, 3-7, 9, and 11-15 of commonly assigned 18/878,991. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/878,991, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments and Declaration
Applicant's arguments filed 5/8/26 have been fully considered but they are not persuasive. Arguments relevant to the current grounds of rejection will be addressed below.
Applicant argues beginning on page 10 that because the present invention relies on the use of mechanical processes instead of chemical processes, the resulting biopolymer product is incomparable to existing biopolymer compositions.
This is not found persuasive. First, the claims are directed to a product and not to a method of making. “[E]ven 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, Davidson et al. disclose formulations which anticipate and render obvious the claimed compositions. In addition, Davidson et al. also teach a step of homogenizing said chitosan suspension with a high shear forming a homogenized chitosan suspension (e.g. claim 13; column 7, lines 11-end; Examples).
Applicant further argues, beginning on page 14 that Davidson (individually or in combination) does not teach or suggest a suspension of biopolymer that is both stable and homogeneous in water. Applicant further argues that Davidson requires dissolving chitosan in a aqueous acidic solution. Applicant further argues in the Declaration of Naseri the structural differences between the instant chitosan and the chitosan prepared by Li and Davidson.
This is not found persuasive. As above, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In addition, the claims do not exclude the presence of an acid or a neutralization step, and Davidson et al. also teach a step of homogenizing said chitosan suspension with a high shear forming a homogenized chitosan suspension (e.g. claim 13; column 7, lines 11-end; Examples).
In general, Applicant appears to be arguing unclaimed features. Claim 4 requires only a stable homogeneous paste, an ointment, a cream, a lotion, a gel or a milk, comprising chitin, chitosan or a mixture thereof and a polar solvent, which is met by Davidson as described supra. While the composition of Davidson may be made by a process which differs from the process used by Applicant, there is no evidence that the composition as claimed could not be made by Davidson. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The structural differences pointed to by Applicant (WRV, WEP, SEM, BET surface area,) while present in the Naseri declaration, are not claimed, and in the case of WRV, WEP, and surface area, also do not have support in the Specification as filed. Furthermore, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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