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
This action is in response to the papers filed June 22, 2026.
Election/Restrictions
Applicant has elected without traverse the invention of Group I, claim(s) 2-8, 10-14, and 16-17, drawn to a hydrogel composition comprising a chloroplast and a chloroplast transit peptide, and a microcapsule comprising said hydrogel composition.
Claims 1-25 are pending.
Claims 9, 15, and 18-25 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim 1 links Groups I-II.
The restriction requirement between the linked inventions is subject to the nonallowance of the linking claim(s), Claim 1.
Upon the indication of allowability of the linking claim(s), the restriction requirement as to the linked inventions shall be withdrawn and any claim(s) depending from or otherwise requiring all the limitations of the allowable linking claim(s) will be rejoined and fully examined for patentability in accordance with 37 CFR 1.104 Claims that require all the limitations of an allowable linking claim will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
Applicant(s) are advised that if any claim(s) including all the limitations of the allowable linking claim(s) is/are presented in a continuation or divisional application, the claims of the continuation or divisional application may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Where a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP §804.01.
Claims 1-8, 10-14, and 16-17 are under consideration.
Priority
This application is a 371 of PCT/KR2022/003838 filed on March 18, 2022.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).
While a certified copy of the foreign patent application KOREA 10-2021-0035982 filed on March 19, 2021 is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Information Disclosure Statement
Applicant has filed Information Disclosure Statements on September 18, 2023 and August 20, 2024 that have been considered.
The signed and initialed PTO Forms 1449 are mailed with this action.
Specification
1. The disclosure is objected to because of the following informalities:
The specification discloses values such as “101/ml”, to “1010/ml” (e.g. [47, 118, 222]), and “1*108” and “2*108” (e.g. [161, 169, 172, 191, 216-219]), each of which is incorrect and/or improper scientific nomenclature.
Note: the Examiner does not cite all paragraphs in which the incorrect and/or improper scientific nomenclature is used.
Applicant should review the entire specification, as that is their burden, and amend all deficient paragraphs to use correct scientific nomenclature. Failure to do so will be considered a non-compliant amendment.
Appropriate correction is required.
Claim Objections
2. Claim 8 is objected to because of the following informalities: the word “hydrogen” should be “hydrogel”.
Appropriate correction is required.
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.
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.
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.
3. Claim 2 is 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 1 recites a hydrogel composition comprising a chloroplast transit peptide (CTP).
Claim 2 recites wherein the CTP binds to a chloroplast outer membrane.
Either this is an inherent property of (that naturally flows from) the CTP of Claim 1, or it is not, and something structural of the CTP of independent Claim 1 must change.
To the extent it is an inherent property of (that naturally flows from) the CTP of the independent claim, then the instant claim fails to further limit the independent claim.
Furthermore, in regard to instant claims, it is noted that the “wherein the CTP binds to a chloroplast outer membrane” clause does not recite any additional structure(s), but simply states a characterization or conclusion of the results of CTP positively recited in Claim 1. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.").
The specification fails to disclose a CTP (Claim 1) that does NOT also bind to a chloroplast outer membrane (Claim 2).
'Even if such a phrase did hold patentable weight, the phrase would likely be rejected under 35 USC 112(b) for being indefinite because such a phrase would amount to a 'functional limitation' whereby one of ordinary skill in the art would essentially need to 'guess' what steps must occur in the claim, in addition to the positively-recited method steps, in order to result in 'wherein the....' (the 'intended result' phrase in the claim).
To the extent Applicant argues otherwise, then see 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejection below.
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.
4. Claims 6, 10-13, and 16 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 1 recites a hydrogel composition comprising a chloroplast transit peptide (CTP).
Claim 6 recites wherein the CTP increases oxygen generation of the chloroplast.
Claim 10 recites wherein the hydrogel composition generates oxygen upon light irradiation.
Claim 11 recites wherein the hydrogel composition generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml.
Claim 12 recites wherein the hydrogel composition generates oxygen upon light irradiation performed at a temperature of 20C to 40C.
Claim 13 recites wherein the hydrogel composition generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes.
Claim 16 recites wherein the hydrogel composition is for delivering oxygen to a cell or a tissue.
Claims 6, 10-13 and 16 recite intended uses. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, then see 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections below.
Either the intended use/functional properties of Claims 6, 10-13, and 16 are inherent properties of (that naturally flows from) the hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively, or they are not, and something structural of the hydrogel composition comprising a chloroplast and a CTP of independent Claim 1 must change, concordantly and respectively.
To the extent they are inherent properties of (that naturally flows from) the hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively, then the instant claim(s) fail(s) to further limit the independent claim, concordantly and respectively.
Furthermore, in regard to instant claims, it is noted that the “wherein” clauses do not recite any additional structure(s), but simply state a characterization or conclusion of the hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.").
The specification fails to disclose hydrogel composition comprising a chloroplast and a CTP (Claim 1) that does NOT also:
i) increases oxygen generation of the chloroplast (Claim 6);
ii) generates oxygen upon light irradiation (Claim 10);
iii) generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml (Claim 11);
iv) generates oxygen upon light irradiation performed at a temperature of 20C to 40C (Claim 12);
v) generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes (Claim 13); and/or
vi) delivering oxygen to a cell or a tissue (Claim 16).
'Even if such a phrase did hold patentable weight, the phrase would likely be rejected under 35 USC 112(b) for being indefinite because such a phrase would amount to a 'functional limitation' whereby one of ordinary skill in the art would essentially need to 'guess' what steps must occur in the claim, in addition to the positively-recited method steps, in order to result in 'wherein the....' (the 'intended result' phrase in 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.
5. Claims 6, 10-13, and 16 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.
The Examiner incorporates herein the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
Claims 6, 10-13 and 16 recite intended uses. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
Either the intended use/functional properties of Claims 6, 10-13, and 16 are inherent properties of (that naturally flows from) the hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively, or they are not, and something structural of the hydrogel composition comprising a chloroplast and a CTP of independent Claim 1 must change, concordantly and respectively.
The claim denotes that not all of the CTPs and/or hydrogels comprising a chloroplast and a CTP of the independent claim are able to achieve the functional property(ies) recited in the dependent claim(s).
To the extent they are not inherent properties of (that naturally flows from) the CTP and/or hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively, then something must change. The claims are considered to be indefinite for failing to recite the structure that is necessary and sufficient to cause the recited functional language, concordantly and respectively.
The claims are considered incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01.
Furthermore, in regard to instant claims, it is noted that the “wherein” clauses do not recite any additional structure(s), but simply state a characterization or conclusion of the hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.").
The specification fails to disclose hydrogel composition comprising a chloroplast and a CTP (Claim 1) that does NOT also:
i) increases oxygen generation of the chloroplast (Claim 6);
ii) generates oxygen upon light irradiation (Claim 10);
iii) generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml (Claim 11);
iv) generates oxygen upon light irradiation performed at a temperature of 20C to 40C (Claim 12);
v) generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes (Claim 13); and/or
vi) delivering oxygen to a cell or a tissue (Claim 16).
'Even if such a phrase did hold patentable weight, the phrase would likely be rejected under 35 USC 112(b) for being indefinite because such a phrase would amount to a 'functional limitation' whereby one of ordinary skill in the art would essentially need to 'guess' what steps must occur in the claim, in addition to the positively-recited method steps, in order to result in 'wherein the....' (the 'intended result' phrase in the claim).
6. Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
Claim 16 recites wherein the hydrogel composition is for delivering oxygen to a cell or a tissue.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
A hydrogel composition comprising a chloroplast and a CTP which is “for delivering oxygen to a cell or a tissue”, as opposed to a hydrogel composition comprising a chloroplast and a CTP which is NOT “for delivering oxygen to a cell or a tissue”, is considered an arbitrary and subjective determination.
The instant claim as a whole does not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
When functional claim language is found indefinite, it typically lacks an adequate written description under §112(a), because an indefinite, unbounded functional limitation would cover a plurality of undisclosed structures and/or method steps of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. Thus, in most cases, a §112(b) rejection that is based on functional language having unclear (or no) claim boundaries should be accompanied by a rejection under §112(a) based on failure to provide a written description for the claim. See MPEP 2173.05(g).
7. Claim(s) 1-4, 6-8, 10-14, and 16-17 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.
The Examiner incorporates herein the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejections.
Claim 1 recites a hydrogel composition comprising a chloroplast transit peptide (CTP).
Claim 2 recites wherein the CTP binds to a chloroplast outer membrane.
Claim 6 recites wherein the CTP increases oxygen generation of the chloroplast.
Claim 10 recites wherein the hydrogel composition generates oxygen upon light irradiation.
Claim 11 recites wherein the hydrogel composition generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml.
Claim 12 recites wherein the hydrogel composition generates oxygen upon light irradiation performed at a temperature of 20C to 40C.
Claim 13 recites wherein the hydrogel composition generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes.
Claim 16 recites wherein the hydrogel composition is for delivering oxygen to a cell or a tissue.
Claims 6, 10-13, and 16 recite intended uses. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
Either the intended use/functional properties of Claims 2, 6, 10-13, and 16 are inherent properties of (that naturally flows from) the hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively, or they are not, and something structural of the hydrogel composition comprising a chloroplast and a CTP of independent Claim 1 must change, concordantly and respectively.
The claim denotes that not all of the CTPs and/or hydrogels comprising a chloroplast and a CTP of the independent claim are able to achieve the functional property(ies) recited in the dependent claim(s).
To the extent they are not inherent properties of (that naturally flows from) the CTP and/or hydrogel composition comprising a chloroplast and a CTP of Claim 1, concordantly and respectively, then something must change. The claims are considered to lack adequate written description for failing to recite the structure that is necessary and sufficient to cause the recited functional language, concordantly and respectively.
The “wherein” clauses do not recite any additional structure(s), and merely state functional characteristics without providing any indication about how the functional characteristics is/are provided, concordantly and respectively. The functional characteristics do not follow from (are not an inherent property(ies) of) the CTP structure and/or the hydrogel composition comprising a chloroplast and a CTP of Claim 1, and thus the ordinary artisan would not know what modification(s) to the CTP and/or the hydrogel composition comprising a chloroplast and a CTP of Claim 1 must be made in order to fulfill the instant recitations.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
The specification discloses examples whereby the CTP peptides may be of a length of 10 to 21 amino acids (e.g. [34-35]).
The breadth of the claims encompasses an enormously vast genus of about 2x10^27 structurally and functionally undisclosed peptides that are to have the functional properties of being a “chloroplast transit peptide” (20^21 = about 2x10^27; calculator.net/exponent-calculator.html; last visited June 23, 2026).
The claims fail to recite, and the specification fails to disclose, a first peptide of the enormously vast genus of about 2x10^27 structurally and functionally undisclosed peptides that does NOT have the functional property of being a “chloroplast transit peptide”, as opposed to a second peptide of the enormously vast genus of about 2x10^27 structurally and functionally undisclosed peptides that necessarily and predictably has the functional property of being a “chloroplast transit peptide”, for example.
The claims fail to recite, and the specification fails to disclose what modification(s) to a first peptide of the enormously vast genus of about 2x10^27 structurally and functionally undisclosed peptides that does NOT have the functional property of being a “chloroplast transit peptide”, transforms said first peptide into one that is now necessarily and predictably capable of being a “chloroplast transit peptide”, for example.
The claims fail to recite, and the specification fails to disclose, a first peptide of the enormously vast genus of about 2x10^27 structurally and functionally undisclosed peptides that, while having the functional properties of being a “chloroplast transit peptide”, does NOT have the functional property of “binds to a chloroplast outer membrane”, for example.
The claims fail to recite, and the specification fails to disclose what modification(s) to a first “chloroplast transit peptide” of the enormously vast genus of about 2x10^27 structurally and functionally undisclosed peptides that does NOT have the functional property of “binds to a chloroplast outer membrane”, transforms said first CTP into one that is now necessarily and predictably capable of “binds to a chloroplast outer membrane”, for example.
Accordingly, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that the applicant is in possession of the enormously vast genus of about 2x10^27 structurally and functionally undisclosed peptides that necessarily and predictably has the functional property(ies) of:
i) being a “chloroplast transit peptide”; and/or
ii) “binds to a chloroplast outer membrane”,
at the time the application was filed.
Rather, the only CTP species disclosed are SEQ ID NO’s:1-4.
The claims fail to recite, and the specification fails to disclose, a first hydrogel composition comprising a chloroplast and a CTP that does NOT have the functional property of “generates oxygen upon light irradiation” (Claim 6), as opposed to a second hydrogel composition comprising a chloroplast and a CTP that necessarily and predictably has the functional property of “generates oxygen upon light irradiation” (Claim 6), for example.
The claims fail to recite, and the specification fails to disclose how to transform or otherwise modify a first hydrogel composition comprising a chloroplast and a CTP that does NOT have the functional property of “generates oxygen upon light irradiation” (Claim 6), into a second hydrogel composition comprising a chloroplast and a CTP that now necessarily and predictably has the functional property of “generates oxygen upon light irradiation” (Claim 6), for example.
The claims fail to recite, and the specification fails to disclose, a first hydrogel composition comprising a chloroplast and a CTP that does NOT have the functional property of “generates oxygen upon light irradiation” (Claim 10), as opposed to a second hydrogel composition comprising a chloroplast and a CTP that necessarily and predictably has the functional property of “generates oxygen upon light irradiation” (Claim 10), for example.
The claims fail to recite, and the specification fails to disclose how to transform or otherwise modify a first hydrogel composition comprising a chloroplast and a CTP that does NOT have the functional property of “generates oxygen upon light irradiation” (Claim 10), into a second hydrogel composition comprising a chloroplast and a CTP that now necessarily and predictably has the functional property of “generates oxygen upon light irradiation” (Claim 10), for example.
The claims fail to recite, and the specification fails to disclose, a first hydrogel composition comprising a chloroplast and a CTP that, while having the functional property of “generates oxygen upon light irradiation” (Claim 10), does NOT have the functional property of “generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml” (Claim 11), as opposed to a second hydrogel composition comprising a chloroplast and a CTP that necessarily and predictably has the functional property of “generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml” (Claim 11), for example.
The claims fail to recite, and the specification fails to disclose how to transform or otherwise modify a first hydrogel composition comprising a chloroplast and a CTP that, while having the functional property of “generates oxygen upon light irradiation” (Claim 10), does NOT have the functional property of “generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml” (Claim 11), into a second hydrogel composition comprising a chloroplast and a CTP that now necessarily and predictably has the functional property of “generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml” (Claim 11), for example.
The claims fail to recite, and the specification fails to disclose, a first hydrogel composition comprising a chloroplast and a CTP that, while having the functional property of “generates oxygen upon light irradiation” (Claim 10), does NOT have the functional property of “generates oxygen upon light irradiation performed at a temperature of 20C to 40C” (Claim 12), as opposed to a second hydrogel composition comprising a chloroplast and a CTP that necessarily and predictably has the functional property of “generates oxygen upon light irradiation performed at a temperature of 20C to 40C” (Claim 12), for example.
The claims fail to recite, and the specification fails to disclose how to transform or otherwise modify a first hydrogel composition comprising a chloroplast and a CTP that, while having the functional property of “generates oxygen upon light irradiation” (Claim 10), does NOT have the functional property of “generates oxygen upon light irradiation performed at a temperature of 20C to 40C” (Claim 12), into a second hydrogel composition comprising a chloroplast and a CTP that now necessarily and predictably has the functional property of “generates oxygen upon light irradiation performed at a temperature of 20C to 40C” (Claim 12), for example.
The claims fail to recite, and the specification fails to disclose, a first hydrogel composition comprising a chloroplast and a CTP that, while having the functional property of “generates oxygen upon light irradiation” (Claim 10), does NOT have the functional property of “generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes” (Claim 13), as opposed to a second hydrogel composition comprising a chloroplast and a CTP that necessarily and predictably has the functional property of “generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes” (Claim 13), for example.
The claims fail to recite, and the specification fails to disclose how to transform or otherwise modify a first hydrogel composition comprising a chloroplast and a CTP that, while having the functional property of “generates oxygen upon light irradiation” (Claim 10), does NOT have the functional property of “generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes” (Claim 13), into a second hydrogel composition comprising a chloroplast and a CTP that now necessarily and predictably has the functional property of “generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes” (Claim 13), for example.
The claims fail to recite, and the specification fails to disclose, how to transform or otherwise modify a first hydrogel composition comprising a chloroplast and a CTP (Claim 1) that does NOT have the functional property(ies) of:
i) “generates oxygen upon light irradiation” (Claim 6);
ii) “generates oxygen upon light irradiation” (Claim 10);
iii) “generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml” (Claim 11);
iv) “generates oxygen upon light irradiation performed at a temperature of 20C to 40C” (Claim 12);
v) “generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes” (Claim 13), and/or
vi) “for delivering oxygen to a cell or a tissue” (Claim 16), concordantly and respectively, into a second hydrogel composition comprising a chloroplast and a CTP that is now necessarily and predictably has the functional property(ies) of:
i) “generates oxygen upon light irradiation” (Claim 6);
ii) “generates oxygen upon light irradiation” (Claim 10);
iii) “generates oxygen upon light irradiation performed at an oxygen concentration of 10^1/ml to 10^10/ml” (Claim 11);
iv) “generates oxygen upon light irradiation performed at a temperature of 20C to 40C” (Claim 12);
v) “generates oxygen upon light irradiation performed 1-5 times for 10-50 minutes at intervals of 10-50 minutes” (Claim 13), and/or
vi) “for delivering oxygen to a cell or a tissue” (Claim 16), concordantly and respectively, for example.
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
Dependent claims are included in the basis of the rejection because they do not clarify the nature of the corresponding structure that is necessary and sufficient to cause the recited functional language.
8. Claim 14 is 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.
The claim recites wherein the chloroplasts present in the hydrogel are at a concentration of 10^1 to 10^10/ml.
The claim is considered indefinite because the claim fails to recite the reference volume of the hydrogel from which the chloroplast concentration of 10^1 to 10^10/ml is to be determined. The breadth of the claimed hydrogel reasonably encompasses small hydrogel beads to nanobeads from which one simply cannot ascertain the resulting volume and/or concentration.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
The instant claim as a whole does not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
9. Claims 1-4, 6-8, 10-14, and 16 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Gisby et al (1987; of record) in view of Thagun et al (available online October 23, 2019; of record), Eseverri et al (available online September 25, 2020; of record), Sandvig et al (2014; of record), Lang et al (available online September 1, 2020; of record), and CoPilot search (microgram chlorophyll per chloroplast; last accessed June 24, 2026).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
Gisby et al is considered relevant prior art for having taught the use of alginate hydrogel beads to encapsulate chloroplasts (e.g. pg 443, “We have routinely used alginate to entrap chloroplasts”; pgs 444-445, Alginate Beads).
Gisby et al taught that “Alginate is probably the most often used of the gel entrapment matrices.” (e.g. pg 441, para 2).
Gisby et al do not teach wherein the alginate/chloroplast composition further comprises chloroplast transit peptides.
However, prior to the effective filing date of the instantly claimed invention, Thagun et al is considered relevant prior art for having taught a nanoparticle composition comprising the artisan’s nucleic acid molecule of interest and chloroplast targeting peptides (syn. chloroplast transit peptides) from chloroplast outer envelope protein 34 (OEP34) (e.g. pg 2, col. 1; as per instant Claim 4), thereby delivering the nucleic acid molecules to chloroplasts (e.g. Figure 1).
Eseverri et al is considered relevant prior art for having taught chloroplast transit peptide fused to the artisan’s protein of interest, e.g. GFP, capable of binding the target receptors on the outer surface of the chloroplast (e.g. pg 2, col. 1, “binding receptors associated with...”).
Sandvig et al is considered relevant prior art for having taught an alginate hydrogel modified to comprise a peptide ligand that is bound by the artisan’s cell type of interest, said hydrogel encapsulating the artisan’s cell of interest (e.g. Abstract, “OEC encapsulation resulted in cell survival”; Figures 4-6), whereby tailoring peptide substituted alginates with a precise and flexible composition, conserving the gel forming properties is relevant for the use of alginate in tissue engineering (Abstract).
Lang et al is considered relevant prior art for having taught a composition, e.g. maleimide beads (e.g. pg 5, col. 1) functionalized to comprise chloroplast-specific membrane anchor sequences (syn. chloroplast transit peptide) with which to capture chloroplasts.
Resolving the level of ordinary skill in the pertinent art.
People of the ordinary skill in the art will be highly educated individuals such as medical doctors, scientists, or engineers possessing advanced degrees, including M.D.'s and Ph.D.'s. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in chemistry, biology, and drug delivery vehicles, including layer-by-layer and hydrogel bead technologies, and the formation of porous hydrogels encapsulating chloroplasts. Therefore, the level of ordinary skill in this art is high.
"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at ___, 82 USPQ2d at 1396.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to modify a hydrogel comprising chloroplasts (Gisby et al) to further comprise chloroplast transit peptides with motivation and a reasonable expectation of success because M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” Those of ordinary skill in the art previously recognized the scientific and technical concepts that:
i) hydrogel matrices, including alginate, can be successfully modified to comprise the artisan’s peptide of interest that is bound by the artisan’s target cell of interest, thereby forming a hydrogel composition comprising the peptide and the target cell interest (Sandvig et al); and
ii) chloroplast targeting/transit peptides have been successfully reduced to practice to bind and/or deliver the artisan’s complex of interest to chloroplasts (Thagun et al, Eseverri et al, Lang et al),
and thus the ordinary artisan would have had a reasonable expectation of success that a hydrogel matrix modified to comprise chloroplast targeting/transit peptides would predictably bind to chloroplasts, thereby affixing or otherwise stabilizing the chloroplasts to the hydrogel matrix.
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claim 2, the claim does not further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejection.
Nevertheless, Eseverri et al taught wherein the transit peptides bind the targeting receptors associated with the translocons at the outer/inner plastid envelope membrane (e.g. pg 2, col. 1).
With respect to Claim 6, the claim does not further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
Nevertheless, Gisby et al taught wherein the chloroplasts entrapped within the hydrogel are functionally able to generate oxygen (e.g. pg 442, para 4; pg 443, para 2, “retained activity”; Table 1).
With respect to Claim 10, the claim does not further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 11, the claim does not further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 12, the claim does not further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 13, the claim does not further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 16, the claim does not further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph rejection.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitations do not contain any further structural limitations with respect to the Claim 1 hydrogel composition comprising a chloroplast and a CTP (see MPEP §2114).
"Products of identical chemical composition can not have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 14, Gisby et al taught wherein alginate hydrogel comprising chloroplasts were formed using chloroplasts containing at least 100 ug total chlorophyll in a volume of 2ml (e.g. pg 444, para 4) or 1mg/ml chlorophyll in a volume of 1ml (e.g. pg 447, last para) in a volume of 2ml, whereby chlorophyll content is directly related to the chlorophyll number (See Kwak et al, 2018; of record, pg 8, col. 2).
Gisby et al do not teach ipsis verbis the chloroplast concentration is 10^1/ml to 10^10/ml.
However, the "mere existence of differences between the prior art and an invention does not establish the invention's nonobviousness." Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may not be "so great as to render the [claim] nonobvious to one reasonably skilled in the art."Id.
CoPilot evidences that the art recognizes that the amount of chlorophyll per chloroplast may vary between 0.1ug to 10ug to 100ug.
100ug chlorophyll (Gisby et al) is equivalent to about 1, 10, or 1000 chloroplasts/ml.
1mg (syn. 1000ug chlorophyll (Gisby et al)) is equivalent to about 10, 100, or 10,000 chloroplasts/ml.
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). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are close enough that one skilled in the art would have expected them to have the same properties. See M.P.E.P. §2144.05(I).
Instant specification fails to disclose an element of criticality for a chloroplast hydrogel formed using at least 100 ug total chlorophyll or 1mg/ml chlorophyll (syn. 10^1/ml, 10^2/ml, 10^3/ml, or 10^4 chloroplasts/ml of Gisby et al), as opposed to the at least 10 chloroplasts/ml unit of measurement recited in Claim 14.
With respect to Claims 3-4, Thagun et al taught wherein the CTP is derived from OEP34 (e.g. pg 2, col. 1, “CTP; KH9-OEP34”).
Lang et al taught wherein the CTP is derived from a chloroplast outer envelope protein (e.g. pg 3, col. 1, “anchor peptide OEP7”).
With respect to Claim 7, Gisby et al taught wherein the hydrogel comprises alginate (e.g. pg 441, para 2, “Alginate is probably the most often used of the gel entrapment matrices.”; pg 444, para 2, “alginate….for the immobilization of chloroplasts”).
Sandvig et al taught wherein the hydrogel comprises alginate (e.g. Title; Abstract conclusion, “We demonstrate herein a unique technique for tailoring peptide substituted alginates with a precise and flexible composition, conserving the gel forming properties relevant for the use of alginate in tissue engineering”).
With respect to Claim 8, Sandvig et al taught wherein the heterologous peptide is gelated by binding a peptide terminus with an alginate terminus (e.g. Figure 1). Instant “terminus” is recited at a high level of generality, and is considered to reasonably read upon any motif on the alginate polymer chemically modified to bind the peptide, as evidenced by instant application Figure 1, illustrating an alginate polymer multiply decorated with the CTP, substantively similar to what Sandvig et al taught.
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
10. Claims 3-5 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Gisby et al (1987; of record) in view of Thagun et al (available online October 23, 2019; of record), Eseverri et al (available online September 25, 2020; of record), Sandvig et al (2014; of record), Lang et al (available online September 1, 2020; of record), and CoPilot search (last accessed June 24, 2026; of record), as applied to Claims 1-4, 6-8, 10-14, and 16 above, and in further view of Yoshizumi et al (available online March 30, 2018; of record in IDS).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
Thagun et al taught wherein the CTP is derived from OEP34 (e.g. pg 2, col. 1, “CTP; KH9-OEP34”).
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claims 3-5, Yoshizumi et al is considered relevant prior art for having taught wherein the CTP comprises the amino acid sequence of SEQ ID NO:1, which is derived from AtOEP34 (e.g. Figure 1a, MFAFQYLLVM).
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first OEP34 chloroplast transit peptide, as taught by Thagun et al, with a second OEP34 chloroplast transit peptide, to wit, comprising the amino acid sequence of SEQ ID NO:1, as taught by Yoshizumi et al, in a hydrogel composition comprising a chloroplast and a chloroplast transit peptide with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute a first OEP34 chloroplast transit peptide with a second OEP34 chloroplast transit peptide, to wit, comprising the amino acid sequence of SEQ ID NO:1, in a hydrogel composition comprising a chloroplast and a chloroplast transit peptide because Yoshizumi et al taught and successfully demonstrated that the OEP34 chloroplast transit peptide comprising the amino acid sequence of SEQ ID NO:1 is readily synthesized (e.g. pg 1583, col. 1, Methods, “synthesized via standard… peptide synthesis”) and targets both plant and other multicellular organisms (e.g. Abstract).
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
11. Claims 7 and 17 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Gisby et al (1987; of record) in view of Thagun et al (available online October 23, 2019; of record), Eseverri et al (available online September 25, 2020; of record), Sandvig et al (2014; of record), Lang et al (available online September 1, 2020; of record), and CoPilot search (last accessed June 24, 2026; of record), as applied to Claims 1-4, 6-8, 10-14, and 16 above, and in further view of Feng et al (Immobilization of Coacervate Microcapsules in Multilayer Sodium Alginate Beads for Efficient Oral Anticancer Drug Delivery, BioMacromolecules 15: 985-996, 2014).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
Neither Gisby et al, Thagun et al, Eseverri et al, Sandvig et al, nor Lang et al teach wherein the hydrogel composition further comprises a microcapsule.
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claim 17, Feng et al is considered relevant prior art for having taught the encapsulation of alginate beads comprising the artisan’s biomolecules of interest within a synthetic microcapsule (entire paper).
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to modify a hydrogel comprising a chloroplast and CTP to further comprise a microcapsule layer with a reasonable expectation of success because those of ordinary skill in the art have long-recognized and successfully reduced to practice the ability to encapsulate hydrogels comprising the artisan’s biomolecule(s) within a microcapsule, as said microcapsule may provide pH-responsive properties, stability, and/or controlled release of the artisan’s biomolecule(s) (Feng et al, Introduction).
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claim 7, Gisby et al taught wherein the hydrogel comprises alginate (e.g. pg 441, para 2, “Alginate is probably the most often used of the gel entrapment matrices.”; pg 444, para 2, “alginate….for the immobilization of chloroplasts”).
Sandvig et al taught wherein the hydrogel comprises alginate (e.g. Title; Abstract conclusion, “We demonstrate herein a unique technique for tailoring peptide substituted alginates with a precise and flexible composition, conserving the gel forming properties relevant for the use of alginate in tissue engineering”).
Feng et al taught wherein the hydrogel comprises alginate (e.g. Title; entire paper).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
Citation of Relevant Prior Art
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Polanska et al (Viability, ultrastructure and cytokinin metabolism of free and immobilized tobacco chloroplasts, Biotechnol. Letters 26: 1549-1555, 2004; of record) is considered relevant prior art for having taught the use of alginate hydrogel beads to encapsulate chloroplasts (e.g. pg 1550, col. 2, Methods).
Kwak et al (Polymethacrylamide and Carbon Composites that Grow, Strengthen, and Self-Repair using Ambient Carbon Dioxide Fixation, Advanced Materials 30: e1804037, 10 pages, doi.org/10.1002/adma.201804037; available online October 9, 2018; of record) is considered relevant prior art for having taught a hydrogel composition comprising chloroplasts (e.g. Figure 1a).
Conclusion
13. No claims are allowed.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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