Detailed Office Action
The communication 10/17/2025 has been entered and fully considered.
Claim 1 has been amended. Claims 1-20 are pending with claims 9-20 withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 10/17/2025 is acknowledged.
Finality
Although the Examiner maintains the same headings of rejections the instant action has been made a second action non-final. The previous rejection when calculating mm/MDa did not multiply by 1,000,000. Therefore when calculating 170 nm/12,000,000 the previous action showed 0.0000141 while is should have been 14.2 mm/MDa. The rejections and arguments have been updated to reflect the corrected calculations.
Response to Arguments and declaration
The Examiner withdraws the ODP rejections.
The declaration argues that the SEALEY reference does not necessarily have the claimed structural density for the claimed ranges of SEALEY [comparative examples 1-6; par. 7-10]. The applicant argues that at least comparative example 5 shows a MW and an Rg that fall within the preferred ranges of 12 MDa -18 MDa and an Rg of at least about 170 nm [par. 9].
In response the Examiner agrees that 12-18 MDa is a preferred range. In the rejection the Examiner stated that “The Examiner takes the position that by listing greater than 150 nm and greater than 170 nm SEALEY has support for the range of 150-170 nm [0085; 0078].”. Given a range of 12-18 MDa and a range of 150-170 nm all possible values of Rg/Mw are less than about 15 sufficient for anticipation.
The applicant to overcome the anticipation rejection would need to argue that it is improper to make the range of 150-170 argued by the Examiner. It is the Examiner’s position that the case law supports the Examiner’s conclusion.
In the precedential decision RAI Strategic Holdings, Inc. v. Philip Morris Products S.A., No. 22-1862 (Fed. Cir. Feb. 9, 2024) the CAFC held that the end-points of two ranges provide sufficient written descriptive support for another range based upon end-points.
Thus, we see no evidence suggesting that the broad described ranges of “about 75% to about 125%,” “about 80% to about 120%, about 85% to about 115%, or about 90% to about 110% the length of the inhalable substance medium” disclose a different invention than the claimed range of “about 75% to about 85%.” In other words, under the facts of this particular case, there is no evidence that the claimed subrange results in a different invention than the invention disclosed in the specification. Accordingly, for all of the above reasons, we conclude that no reasonable fact finder could find that the claimed subrange is not within the appellant’s invention.
The declarant argues that Rg and MW cannot not be independently controlled to obtain the RG/MW value of the claim.
In response in the anticipation rejection given the ranges of 12-18 MDa and 150-170 nm all the possible combinations result in claimed Rg/MDa values. On the secondary rejection (obviousness) given a fixed 12-18 MDa it is obvious to explore the range of greater than 150 nm of the radius of gyration. That is the both variables are not independently controlled. The MW would be fixed between the preferred range of 12-18 million DA while it is the radius of gyration that is being changed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 1-8 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. 2024/0218603 SEALEY et al., hereinafter SEALEY.
The instant invention has an earliest effective filing date of based on the instant provisional application.
SEALEY has a filing date of 6/15/2023. SEALEY has a provisional filing date of 6/22/2022 (63/354,512).
The Examiner finds the provisional application (63/354,512) has support for the subject matter of the pgpub (2024/0218603) and therefore the reference earliest effective filing date (6/22/2022) is before that of the instant invention (8/1/2022) based on the 63/369,985 instant provisional).
The Examiner shows support in the following manner [pgpub paragraph numbers; provisional paragraph numbers].
As for claim 1, SEALEY discloses a UHMW glycoxylated polyvinylamide and glycoxylated cationic polyacrylamide copolymer [0082; 0073]. The polymer has a MW of 12,000,000 to 18,000,000 which falls within the claimed range [0084; 0077]. The radius of gyration is at least about 150 or at least about 170 nm both of which falls within the claimed range [0085;0078]. The Examiner takes the position that by listing greater than 150 nm and greater than 170 nm SEALEY has support for the range of 150-170 nm [0085; 0078].
In the precedential decision RAI Strategic Holdings, Inc. v. Philip Morris Products S.A., No. 22-1862 (Fed. Cir. Feb. 9, 2024) the CAFC held that the end-points of two ranges provide sufficient written descriptive support for another range based upon end-points.
Thus, we see no evidence suggesting that the broad described ranges of “about 75% to about 125%,” “about 80% to about 120%, about 85% to about 115%, or about 90% to about 110% the length of the inhalable substance medium” disclose a different invention than the claimed range of “about 75% to about 85%.” In other words, under the facts of this particular case, there is no evidence that the claimed subrange results in a different invention than the invention disclosed in the specification. Accordingly, for all of the above reasons, we conclude that no reasonable fact finder could find that the claimed subrange is not within the appellant’s invention.
This means that based on the MW and radium of gyration of 150 nm-170 nm the (Rg/Mw) is <15 nm/MDa which falls within the claimed range [170 nm/12,000,000 MW =14.17 nm/MDa].
Given 12,000,000-18,000,000 MW and 150nm to 170 nm the Examiner picked the two points most favorable to the applicant (170 nm and 12,000,000 MW). Choosing 150 nm and 18,000,000 would also anticipate the claim 150 nm/18,000,000 MW = 8.3 nm/MDa. Choosing 150 nm and 12,000,000 would also anticipate the claim 150 nm/12,000,000 MW = 12.5 nm/MDa.
Should the applicant argue that these two points are not sufficient to support a range (150-170 nm) for anticipation purposes then greater than 150 nm is an unbound range and therefore the (Rg/Mw) overlaps as greater than 12.5 nm/MDa (Rg/Rw). SEALEY further recognize that ROG is a result effective variable [0250] and that a larger radius of gyration forms a larger net for bonding [0250]. Conversely too large of a complex causes retention problems [0251]
As for claim 2 and 4-8, the presence of a cationic acrylamide (cAM) is a structural limitation which SEALEY discloses [0082; 0073]. The remainder of the limitations are product-by-process limitation.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
SEALEY teaches a product which meets the claimed properties in instant claim 1. The burden shifts to the applicant to show that the process limitations affect the structure of the product in a non-obvious way.
The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion.
In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.
In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983)
The Examiner takes the position that the process limitations are not defined enough to impart any special structure to the claimed product as important process limitations are not defined enough to impart any special structure to the claimed product (temperature, time, glyoxal concentration, other copolymer concentration, separation techniques of produced polymer, accelerators/initiators added, co-solvents present, and pressure all affect the final structure of the gPAM made).
As for claim 3, the polymer has a MW of 12,000,000 to 18,000,000 which falls within the claimed range [0084; 0077] of the newly claimed structural limitation. The presence of a cationic monomer (A2) is a structural limitation which SEALEY discloses [0082; 0073]. The remainder of the limitations are product-by-process limitation.
SEALEY teaches a product which meets the claimed properties in instant claim 1. The burden shifts to the applicant to show that the process limitations affect the structure of the product in a non-obvious way. The Examiner takes the position that the process limitations are not defined enough to impart any special structure to the claimed product (temperature, time, glyoxal concentration, other copolymer concentration, separation techniques of produced polymer, accelerators/initiators added, co-solvents present, and pressure all affect the final structure of the gPAM made).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTHONY J CALANDRA whose telephone number is (571)270-5124. The examiner can normally be reached Monday-Friday 7:45 AM -4:15 PM.
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ANTHONY J. CALANDRA
Primary Examiner
Art Unit 1748
/Anthony Calandra/Primary Examiner, Art Unit 1748