DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 10/14/2025 are acknowledged.
Previous applicants election of group I claims and elected spices are still remain same. See applicants response filed on 12/22/2023.
Newly added claims 23-24 are subjected to 112(b) and new 103 rejection. Claims are examined to the extent the elected species read the claim limitations.
Applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejection is maintained and modified to address claim amendments.
Response to Arguments
(i) Applicants argue that the Patent Office has not established that the length of the methylene groups in the claimed building blocks is a result effective variable.
As explained in the rejection, cited Schulze teaches varied chain lengths of -CH2- groups, n=3-12, in their compounds and monitor their properties. Increase in chain length starting from n=3, increases in IC50 values until n=5, and then further increase in chain length decrease in IC50 values. So, optimal results are obtained at n=5 through a routine titration. At lower n values steric hindrance may play a role and at higher n values the molecule may be more flexible and may not be suitable for its expected function.
In the same lines, Suzuki also teaches varied chain lengths of -CH2- groups, n=2-7, in their compounds and monitor their properties, specifically it says hydrogelation ability decreases with the increase in the length of alkylene spacer and compound 99 does not form a hydrogel.
Also, O’Flaherty teaches alkylene tethers and their effect on the properties of their disclosed compounds, and based on shown data, the art concludes that linkers of greater length displayed more proficient conjugation of proteins to synthetic polymers, and steric hindrance of shorter tethers results in a reduction in conjugation yield [see abstract, first paragraph in right column in page 2356].
Above teachings suggest that length of methylene chain is result effective variable, and which directly effects the properties of the compound. In other words, cited art teach that the length of -CH2- groups in a given compound directly reflects the overall property of compound, and it can be tunable or optimizable through a routine experimentation, i.e., it is a result effective variable, see the modified rejection in the next section.
In this case, the above teachings can be extrapolated to the teachings of cited art. That means change in the size of methylene groups is expected to change in the property of the building block. Property can be a physical or chemical or both. This is exactly aligned with applicants shown data in the specification.
According to shown data, no unwanted product(s) are obtained with linker 1 (m=2 and n=3) and if n=1, adverse cyclization occurred. In case n=1, a skilled person can expect steric hindrance, and so, side products can be expected. If n=2 or 3, the cleavable group should be more flexible and makes the cleavage more efficient. In other words, shorter length is more rigid or tight compared to longer or flexible length at the cleavage site. This property is expected. For further evidence, see the cited teachings from Schulze, Suzuki and O’Flaherty in the modified rejection.
In example 4, first the linker is linker 1, wherein m=2 and n=3, and second it has poly-lysine tag. There is no comparative data with other linkers, such as n=1-2 and 4-24 etc.
Accordingly, the rejection is clearly justified.
(ii) Applicants argue that the claimed building blocks have comparative unexpected and/or superior properties.
According to shown data, no unwanted product(s) are obtained with linker 1 (m=2 and n=3) and if n=1, adverse cyclization occurred. In case n=1, a skilled person can expect steric hindrance, and so, side products can be expected. If n=2 or 3, the cleavable group should be more flexible and makes the cleavage more efficient. In other words, shorter length is more rigid or tight compared to longer or flexible length at the cleavage site. This property is expected. For further evidence, see the cited teachings from Schulze, Suzuki and O’Flaherty in the rejection.
In example 4, first the linker is linker 1, wherein m=2 and n=3, and second it has poly-lysine tag. There is no comparative data with other linkers, such as n=1-2 and 4-24 etc.
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.
Claims 23-24 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 pre-AIA the applicant regards as the invention.
Claims recite term “stable” in the claim language. The word “stable” is a relative word. It is not clear what the “stable” block encompasses, specifically stable relative to what? Is it stable against specific enzymes or temperature or aqueous medium etc.? In addition the specification fails to define it or provide its definition.
In absence of its clear definition, the metes and bounds of the claim cannot be determined. Accordingly, claims are rendered indefinite.
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 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.
(I) Claims 1-5, 8 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Quaedflieg et al (EP 3299085 A1) in view of Schulze (Bioorg.Med.Chem.Lett., 2010, 20, 2946-2949), Suzuki (Chem.Soc.Rev., 2009, 39, 967-975) and O’Flaherty (ChemBioChem, 2017, 18, 2351-2357).
Quaedflieg et al teach the following compound:
PNG
media_image1.png
332
408
media_image1.png
Greyscale
[see attached abstract from the STN search].
The difference is that the elected species require n=3 and m=2, whereas prior art teach n=1 and m=4. In other words, difference is in the length of -(CH2)- groups.
However, structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties." In re Deuel 34 USPQ2d 1210 at 1214.
The MPEP 2144.09 states that “Compounds which are….homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA).
In addition to above, it is also known in the art that the length of -CH2- groups in a given compound directly reflects the overall property of compound, and it can be optimizable through a routine experimentation, i.e., it is a result effective variable, as evidenced form the following art:
Schulze teaches varied chain lengths of -CH2- groups, n=3-12, in their compounds and monitor their properties, see for example Table 2. Increase in chain length starting from n=3, increases in IC50 values until n=5, and then further increase in chain length decrease in IC50 values. So, optimal results are obtained at n=5 through a routine titration. At lower n values steric hindrance may play a role and at higher n values the molecule may be more flexible and may not be suitable for its expected function.
Suzuki also teaches varied chain lengths of -CH2- groups, n=2-7, in their compounds and monitor their properties, specifically it says hydrogelation ability decreases with the increase in the length of alkylene spacer and compound 99 does not form a hydrogel [see Scheme 5; right column 2nd paragraph in page 973 to left column 1st paragraph in page 974].
O’Flaherty also teaches alkylene tethers and their effect on the properties of their disclosed compounds, and based on shown data, the art concludes that linkers of greater length displayed more proficient conjugation of proteins to synthetic polymers, and steric hindrance of shorter tethers results in a reduction in conjugation yield [see abstract, first paragraph in right column in page 2356].
With regard to recited intended use “for peptide synthesis”, please note that the recitation of “for peptide synthesis” in the instant claim 1, is an intended use of the claimed product.
MPEP 2111.02(11) states that when a claim recites a product with an intended use (i.e. A product “for use as_” or other similar language), that intended use is only given patentable weight if it results in any structural difference to the product itself. If, as is usually the case, the body of the claim fully sets forth all limitations of the claimed invention, and the preamble merely recites an intended use or purpose, then the preamble is not considered as a limitation and is of no significance to claim construction.
In this case, “for peptide synthesis” does not add any structural limitation to the claimed composition. Therefore, this part of the claim is not given patentable weight.
With regard to the recited properties of building block, these are the properties of the product, and are expected in the product obtained from the teachings of cited art.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components and limitations in the claimed building block, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to modify the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed product with a reasonable expectation of success.
(II) Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Quaedflieg et al (EP 3299085 A1) in view of Schulze (Bioorg.Med.Chem.Lett., 2010, 20, 2946-2949), Suzuki (Chem.Soc.Rev., 2009, 39, 967-975) and O’Flaherty (ChemBioChem, 2017, 18, 2351-2357).
Quaedflieg et al teach the following compound:
PNG
media_image1.png
332
408
media_image1.png
Greyscale
[see attached abstract from the STN search].
Differences between Quaedflieg et al and instant claims are as follows:
(i) Quaedflieg et al silent on applicants n=3 and m=2.
(ii) Quaedflieg et al silent on “stable building block for peptide synthesis”;
(iii) Quaedflieg et al silent on recited properties of building block.
With regard to (i) of above, the difference is that the elected species require n=3 and m=2, whereas prior art teach n=1 and m=4. In other words, difference is in the length of -(CH2)- groups.
However, structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties." In re Deuel 34 USPQ2d 1210 at 1214.
The MPEP 2144.09 states that “Compounds which are….homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA).
In addition to above, it is also known in the art that the length of -CH2- groups in a given compound directly reflects the overall property of compound, and it can be optimizable through a routine experimentation, i.e., it is a result effective variable, as evidenced form the following art:
Schulze teaches varied chain lengths of -CH2- groups, n=3-12, in their compounds and monitor their properties, see for example Table 2. Increase in chain length starting from n=3, increases in IC50 values until n=5, and then further increase in chain length decrease in IC50 values. So, optimal results are obtained at n=5 through a routine titration. At lower n values steric hindrance may play a role and at higher n values the molecule may be more flexible and may not be suitable for its expected function.
Suzuki also teaches varied chain lengths of -CH2- groups, n=2-7, in their compounds and monitor their properties, specifically it says hydrogelation ability decreases with the increase in the length of alkylene spacer and compound 99 does not form a hydrogel [see Scheme 5; right column 2nd paragraph in page 973 to left column 1st paragraph in page 974].
O’Flaherty also teaches alkylene tethers and their effect on the properties of their disclosed compounds, and based on shown data, the art concludes that linkers of greater length displayed more proficient conjugation of proteins to synthetic polymers, and steric hindrance of shorter tethers results in a reduction in conjugation yield [see abstract, first paragraph in right column in page 2356].
With regard to (ii) of above, since the compound is obvious over the cited art, and therefore, this property is also obvious over the combination art and is expected.
The recitation “for peptide synthesis” in the claim, is an intended use of the claimed product.
MPEP 2111.02(11) states that when a claim recites a product with an intended use (i.e. A product “for use as_” or other similar language), that intended use is only given patentable weight if it results in any structural difference to the product itself. If, as is usually the case, the body of the claim fully sets forth all limitations of the claimed invention, and the preamble merely recites an intended use or purpose, then the preamble is not considered as a limitation and is of no significance to claim construction.
In this case, “for peptide synthesis” does not add any structural limitation to the claimed composition. Therefore, this part of the claim is not given patentable weight.
With regard to (iii) of above, the recited properties of building block are the properties of the claimed product, and are expected in the product obtained from the teachings of cited art.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components and limitations in the claimed building block, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to modify the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed product with a reasonable expectation of success.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/
Primary Examiner, Art Unit 1658