DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of the invention of Group I, claims 1-12 and 19, and the species of SEQ ID NO: 398 in the reply filed on 06/15/2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement does not follow the rules of PCT restrictions, that no objection to unity of invention was raised during the PCT phase, and that it would not be a burden on the Office to search SEQ ID NOs: 397-401 in a single application. These arguments have been fully considered but have not been found persuasive because, as discussed in the previous Office action, the PCT rules allow for the examination of a product, one single product. None of the scenarios in which inventions share unity that are recited in the PCT rules quoted in Applicant’s remarks and in the previous Office action discuss the examination of multiple distinct products in one application. In addition, restriction is always within the discretion of the Examiner, and the current Examiner of record cannot be held responsible for decisions regarding restriction made by a PCT examiner. Regarding the species election requirement, the Examiner notes that the full scope of claim 1 is significantly broader than the five sequences cited by Applicant, encompassing any polypeptide with endoglucanase activity that meets the structural requirements of instant claim 1, which would pose a significant search burden on the Examiner, contrary to Applicant’s argument.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 06/15/2026 has been entered. Claims 1-12 and 14-21 are pending in this US patent application. Claims 14-18 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, and claims 2-9 are withdrawn as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/15/2026.
Claims 1, 10-12, and 19-20 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 04/10/2024 has been received and considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 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.
Claim 11 recites functional language regarding the linker in the polypeptide of claim 1. The functional language in claim 11 can be interpreted in two distinct ways. In the first interpretation, claim 11 recites an intrinsic property of the linker of claim 1, i.e., all linkers that fall within the structural scope of claim 1 exhibit the property recited in claim 11. In the second interpretation, claim 11 recites a further limitation of the linker of claim 1, i.e., only certain linkers that fall within the scope of claim 1 exhibit the property recited in claim 11. It is unclear which interpretation is intended by Applicant. If Applicant intends the second interpretation, it is unclear what would be the structural boundaries of a linker of claim 1 that would exhibit the function recited in claim 11. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claim 11, rendering it indefinite, and claim 11 is rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claim 11 to recite an intrinsic property of the linker of claim 1. As such, any prior art that reads on claim 1 will be interpreted to read on claim 11 as well.
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 1 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over UniProt listing A0A3S5CXS4_9PEZI, published 04/10/2019, in view of Chen et al., Advanced Drug Delivery Reviews 65: 1357-1369 (2013; cited on the IDS filed 04/10/2024), and Ruiz et al., Scientific Reports 6: 28504 (2016).
UniProt teaches an endoglucanase with 86.9% identity to instant SEQ ID NO: 398 (see entire document, including alignment pasted below; cf. claims 1 and 10-11; see above under Claim Rejections – 35 USC 112 for the Examiner’s interpretation of instant claim 11).
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However, UniProt does not teach a linker that satisfies the structural limitations of instant claim 1.
Chen teaches that proline-rich sequences can serve as rigid linkers that separate the functional domains of proteins more efficiently than flexible linkers and can be easily adjusted in length to achieve an optimal distance between domains (see entire document, including page 1361, left column, paragraph 7, to right column, paragraph 2).
Ruiz teaches that enzymes that degrade cellulose typically feature a catalytic core and an accessory module that mediates absorption to the substrate (see entire document, including page 1, paragraph 2) that are connected by a linker domain (page 2, paragraph 2). Residues were replaced with prolines to increase the rigidity of the linker region (page 2, paragraph 5), and increasing the rigidity of the linker improved the enzyme’s catalytic efficiency, although flexibility in the form of glycine at the extremities of the linker improved enzyme affinity (page 4, paragraph 2).
While UniProt does not teach altering the linker domain in the endoglucanase to a linker that meets the structural requirements of claim 1, it would have been obvious to one of ordinary skill in the art to modify the linker to meet those structural requirements because Chen teaches that rigid, proline-rich linkers can separate the functional domains of proteins more efficiently than flexible linkers and can be easily adjusted in length to achieve an optimal distance between domains and because Ruiz teaches that increasing linker rigidity by replacing residues with prolines, with the exception of glycine residues at the extremities of the linker, improves the catalytic efficiency of cellulolytic enzymes featuring a catalytic core and a substrate binding module. As such, one of ordinary skill in the art would have been motivated to alter the residues of the linker region of the UniProt enzyme in any of the ways that fall within the scope of Chen and Ruiz’s teachings, including manners that fall within the scope of the structural limitations of the linker recited in instant claim 1, and would have a reasonable expectation that doing so would successfully improve the catalytic efficiency of the enzyme.
Therefore, claims 1 and 10-11 are rendered obvious by UniProt in view of Chen and Ruiz and are rejected under 35 U.S.C. 103.
Claims 1, 10-12, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over UniProt listing A0A3S5CXS4_9PEZI, published 04/10/2019, in view of Chen et al., Advanced Drug Delivery Reviews 65: 1357-1369 (2013; cited on the IDS filed 04/10/2024), Ruiz et al., Scientific Reports 6: 28504 (2016), and US patent application publication 2017/0145353 filed by Shang et al., published 05/25/2017.
As discussed above, claims 1 and 10-11 are rendered obvious by UniProt in view of Chen and Ruiz. However, these references do not teach the formulation of the endoglucanase rendered obvious by their combined teachings in a granule with a protease.
Shang teaches granular automatic dishwasher detergents containing enzymes (see entire document, including paragraph 0002). The granule may contain multiple enzymes, including cellulases and proteases (paragraph 0050), and suitable cellulases include endoglucanases (paragraph 0056; cf. claims 12 and 19-20).
While UniProt, Chen, and Ruiz do not teach the inclusion of the endoglucanase rendered obvious by their combined teachings in a granule with a protease, it would have been obvious to one of ordinary skill in the art to do so because Shang teaches that endoglucanases can be combined with proteases in granular form to produce dishwasher detergents. One of ordinary skill in the art would have a reasonable expectation that including the endoglucanase rendered obvious by UniProt, Chen, and Ruiz in the endoglucanase- and protease-containing granule of Shang would successfully result in the production of a granular composition capable of washing dishes in a dishwasher.
Therefore, claims 1, 10-12, and 19-20 are rendered obvious by UniProt in view of Chen, Ruiz, and Shang and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Tuesday-Thursday, 6:30-4:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 09/01/2026
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