DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
2. Claims 35-43 are currently pending. This office action is in response to the amendment filed on 09/26/2025.
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.
3. Claims 38 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.
Concerning claim 38 the claim recites “wherein each of the initiators I1” which renders the claim indefinite as there is no antecedent basis of this I1 in the claim or claim 35 from which the claim depends. Claim 35 recites “I-I’ is an initiator”. For the purpose of art examination it is assumed that the indicated I1 is meant to be the I-I’ recited in claim 35.
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.
4. Claim 38-39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 38 recites initiators of
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None of which recite a structure of
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which is required by claim 35 from which claim 38 depends. As such these structures impermissibly broaden the claim from which they depend.
Claim 39 recites a structure of
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Which has only 6 polymer arms, however claim 37 from which the claim depends and claim 35 from which claim 37 depends requires that the structure has a s value of 9-12 which would require the presence of 9-12 polymer arms which is more than the indicated structure can have and so would impermissibly broaden the scope of the claims from which it depends.
Additionally claim 38 recites structures of
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and
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None of which recite a structure of
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which is required by claim 35 from which claim 39 depends. As such these structures impermissibly broaden the claim from which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
5. Claims 35-37 and 40-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Charles (WO 2007/100902 A2).
Concerning claim 35-37 Charles teaches a polymer having a structure of (X-(Sp1)n)a-L-(K)b (paragraph 00009) where X is a reactive group or a protected from thereof , Sp1 is a spacer group, n is 0 or 1, L is selected from alkyl, cycloalkyl, carboxy alkyl, carboxycycloalkyl, alkoxy alkyl and cyclic alkyl ether, a is an integer from 1-8, b is an integer form 1-8, K is a group of the formula
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Where m is an integer ranging from 2 to 2,000, Q is selected from H methyl and ethyl, and T can be selected from several different groups including a phophorylcholine group where one or more group T is required to include a C1-4 alkyl O-phosphorylcholine group, and E is indicated to be a halo or nucleophilic group. This alkyl phosphoryl choline group would result in the structure of claim 37 where n is an integer from 1-4. The E group would correspond to the claimed end group. A specific example provided is a compound having a structure of (paragraph 0012)
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Particular examples of the polymeric portion of the compounds is given to be poly-hydroxyethylmethacryloyl phosphorylcholine, which corresponds to the structure indicated above where Q is methyl (paragraph 0023 and 0118), and corresponds to the claimed monomer structure of claim 37. Charles further teaches particular examples of the polymeric portion of the compound stated above is given to be poly-hydroxyethylmethacryloyl phosphorylcholine, which corresponds the claimed structure (paragraph 0023 and 0118). Charles further teaches methods of making the polymer by radical polymerization which include (paragraph 0188)
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This indicates the polymer will have a L group which is a branched structure and so will correspond to claimed C of the indicated groups and would be a branched structure.
Charles further teaches that the molecular weight of the branched polymer can be from about 100,000 Daltons to 200,000 Daltons or 200,000 to 250,000 or 250,000 to 300,000 (paragraph 0124-0126) and the polydispersity index is indicated to be preferably less than about 1.5 and more preferably less than 1.15 and are most preferably less than about 1.03 (paragraph 0063). This would indicate at very least an overlapping range with the claimed range of less than 1.2. Charles further indicates that polydispersity can be reduced by post polymerization reaction of the polymer compounds (paragraph 0210) indicating that the polydispersity is known to be controlled to give a preferred polydispersity index.
Charles does not specifically teach that the molecular weight indicated would be a peak molecular weight as measured using multi-angle light scattering. However, a peak molecular weight will be between a number average molecular weight and a weight average molecular weight of a polymer. The molecular weight of Charles is indicated to be a weight average molecular weight (paragraph 0063). The polydispersity index of 1.5 or less taught by Charles would indicate that a peak molecular weight would be expected to be at minimum of 0.666 times the molecular weight of Charles because the peak molecular weight can not be less than the number average molecular weight. Additionally the particular method of multi-angle light scattering would be expected to have a fairly small alteration to the molecular weight value as all such methods are attempting to measure the same value with differing precisions. As such Charles would provide at very least an overlapping range with the claimed range of the peak molecular weight, given the indicated molecular weights and polydispersity index of Charles.
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). See MPEP 2144.05.I.
Charles teaches multiple different polymerization initiators having different structures (paragraph 0191) which includes ATRP initiators which can be alkyl carboxylic acid esters that include a halogen group (paragraph 0193).
Charles teaches a particular polymer structure which has the formula of (paragraph 0243)
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This polymer structure has the claimed structure where C is a phenyl group L4 is a bond, R3 and R4 are each a methyl alkyl group and p is 2. This exemplary polymer differs from the claimed polymer only in that it has a polydispersity index of 1.3 and in that it has a Mp value of 10,000 and an Mw value of 11,500 and that it has 2 polymer arms instead of 9 to 12 polymer arms (paragraph 0243). This structure includes an example of the claimed I structure
However as is stated above Charles teaches an overlapping range with the claimed range of the molecular weight of the polymer and with the polydispersity index of Mw/Mn .
It would have been obvious to one of ordinary skill in the art at the time of invention to alter the peak molecular weight and polydispersity index of the exemplary polymer of Charles to have the claimed peak average molecular weight because Charles teaches an overlapping peak average molecular weight with the claimed peak average molecular weight and an overlapping range with the claimed range of the polydispersity index.
Charles does not specifically teach that the polymer has a number of polymer arms which is 9 or 12. The value of b in the structure indicated above is from 1-8 and corresponds to the number of polymer arms. The gives Charles a range of the number of polymer arms of from 1-8. The claimed value of 9 polymer arms is just outside of this range.
Charles however further teaches that a branched polymer may possess 2 polymer arms and can have 8 or more polymer arms (paragraph 0098).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05.I.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See MPEP 2144.09.I.
It would have been obvious to one of ordinary skill in the art at the time of the invention to alter the number of polymer arms to provide 9 polymer arms having the claimed structure because Charles teaches a polymer having close structural similarity and similar utility such that the polymer would be expected to have similar properties and Charles teaches that more than 8 polymer arms can be used in branched polymers and Charles teaches that the inciated initiator fragment structure can be used to make branched polymers.
Concerning claim 40 and 43 Charles teaches the polymer having 9 arms of claim 35 as is indicated above. Charles further teaches polymeric reagents and conjugates thereof (paragraph 0008) and teaches a conjugate having a structure of (A-Z-(Sp1)n)a-L-(K)b (paragraph 0016) where A is a biologically active agent, Z is the product of the reaction between a group present in said biologically active agent and a reactive group bound to Sp1 or L, Sp1 is a spacer group, n is 0 or 1, L is selected from alkyl, cycloalkyl, carboxy alkyl, carboxycycloalkyl, alkoxy alkyl and cyclic alkyl ether, a is an integer from 1-8, b is an integer form 1-8, K is a group of the formula
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Where m is an integer ranging from 2 to 2,000, Q is selected from H methyl and ethyl, and T can be selected from several different groups including a phosphorylcholine group where one or more group T is required to include a C1-4 alkyl O-phosphorylcholine group, and E is indicated to be a halo or nucleophilic group. The E group would correspond to the claimed end group. A specific example provided is a compound having a structure of (paragraph 0019)
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Particular examples of the polymeric portion of the compounds is given to be poly-hydroxyethylmethacryloyl phosphorylcholine, which corresponds to the structure indicated above where Q is methyl (paragraph 0023 and 0118). Charles further teaches methods of making the polymer by radical polymerization which include (paragraph 0188)
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This indicates the polymer will include a radical polymerization initiator fragment which has the bioactive agent linked to it.
Charles further teaches a particular polymer structure which has the formula of (paragraph 0243)
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This polymer is indicated to be conjugated with Eythropoietin obtained from a trangenic chicken (paragraph 0255), which would correspond to the claimed bioactive agent.
It would have been obvious to one of ordinary skill in the art at the time of filling to alter the polymer of Charles to include a bioactive agent linked to the initiator fragment to give the claimed conjugate because Charles teaches that the polymer can be formed into a conjugate having the claimed structure.
Concerning claim 41 Charles teaches that the biologically active agent can be any one of drugs, antibodies, antibody fragments, vitamins, cofactors, polysaccharides, carbohydrates, steroids, lipids, fats, proteins, peptides, polypeptides, nucleotides, oligonucleotides, polynucleotides, and nucleic acids (paragraph 0031).
Concerning claim 42 Charles further teaches that biologically active agent can include radiolabeled agents such as radiolabeled lym-1 (paragraph 0032). It should be noted that the claim as is currently drafted does not require that the conjugate include one of a radiolabel, a contrast agent, a fluorophore or a dye, but indicates when the function agent is a diagnostic agent that it must fit within these groups. When the functional agent is a bioactive agent as is indicated above then the limitations of the claimed structure would be met.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 35-37, 40-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 7 and 8 of U.S. Patent No. 11,066,465. Although the claims at issue are not identical, they are not patentably distinct from each other because concerning claims 35-37, 40-41, 43 the patent teaches a polymer and polymer antibody conjugate having 9 methacryloyloxyethyl phosphorylcholine polymer arms attached to an initiator fragment having the claimed structure including a branched core group (claim 1) and teaches that the polymer has a polydispersity index of less than about 1.5 (claim 6) and has a molecular weight of between about 300, 000 and about 1,750,000 (claim 5). This is an overlapping range with the claimed range of from 50 kDa to 1,500 kDa and an overlapping range with the claimed range of the polydispersity of less than 1.2.
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). See MPEP 2144.05.I.
It would have been obvious to one of ordinary skill in the art at the time of filling to teach the claimed polymer having the claimed structures and claimed molecular weight properties, because the patent teaches the claimed polymer structure and polydispersity and an overlapping range of the molecular weight with the claimed molecular weight.
Concerning claim 42 the patent teaches that the polymer is conjated to a antibody which would be a bioactive agent and as such the claimed diagnostic agent need not be present. As the claim as is currently drafted does not require that the diagnostic agent be present only that if it is it have the claimed structure patent teaches the claimed limitations.
Allowable Subject Matter
7. Claims 38-39 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or fairly suggest the claimed polymer which is made from an initiator having the claimed structure of claim 38 or which has the particularly indicated branched structure indicated by claim 39.
Response to Arguments
8. Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive. Applicant argues with regard to the rejection over Charles that Charles specifically teaches a structure of (X-(Sp1)n)a-L-(K)b where b is an integer from 1-8. Since K represents the polymer arm in Charles’ structure b would be the number of polymer arms in the structure above. Claim 35 recites a polymer with 9-12 arms and is therefore outside of the scope of the structure taught in Charles. The Office actions points to paragraph 0098 of Charles for teaching that the structure may have 8 or more arms however paragraph 0098 is defining the term branching in reference to the geometry , architecture or overall structure of a polymer and “a branched polymer may possess 2 polymer arms, 3 polymer arms, … 8 polymer arms or more” This definition does not expand what is disclosed or taught about the structure of (X-(Sp1)n)a-L-(K)b. A branched polymer may have 8 or mor arms but the structure disclosed in Charles can only have up tot 8 polymer arms. Furthermore, all the examples and the description in Charles relate to polymer structures that Have 1 or 2 arms and paragraph 0121 only contemplates the sum of a and b to be 3,4,5 or 6. Charles did not enable more than 8 polymer arms structure and in view of this Charles does not render claim 35 obvious.
This argument is not found to be persuasive as Charles teaches a number of arms which ranges from 1-8 which is a range that is next to the claimed range of 9-12.
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05.I.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See MPEP 2144.09.I
As such in combination with Charles indication that branched polymers having 8 or more polymer arms exist, it would have been obvious to one of ordinary skill in the art at the time of filling to alter the polymer of Charles to have one additional polymer arm above the range indicated by Charles to give 9 polymer arms as the amount of polymer arms is indicated to be close to the claimed amount of polymer arms and would have close structural similarity and similar utility. As such the rejection provided above is maintained.
Concerning the double patenting rejection Applicant argues that the double patenting rejection is rendered moot by amendments to the claims.
This argument is not found to be persuasive as claim 1 of the patent teaches a structure of
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Which has the claimed polymer structure present in it and has 9 polymer arms. As such the rejection is maintained.
Conclusion
9. Claims 35-43 are rejected. Claims 38-39 are rejected over 112 issues but are allowable over the prior art of record.
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 DAVID L MILLER whose telephone number is (571)270-1297. The examiner can normally be reached M-F 9:30-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Del Sole can be reached at 571-272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID L MILLER/ Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/ Supervisory Patent Examiner, Art Unit 1763